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AbbVie to Showcase Breadth of Neuroscience Portfolio and Pipeline at American Academy of Neurology 2022 Annual Meeting

-- AbbVie to present 30 abstracts demonstrating its leadership in neuroscience, including continued migraine treatment research across the spectrum of the disease, commitment to patients with advanced Parkinson's disease, and new studies in spasticity and cervical dystonia

ABBVie (NYSE: ABBV) today announced that data from its neuroscience portfolio will be presented at the 2022 American Academy of Neurology (AAN) Annual Meeting, to be held in Seattle from April 2-7 and virtually April 24-26.

The data, which include an updated analysis of AbbVie's newest migraine medicine atogepant (QULIPTA ) along with other results from across its migraine portfolio, underscore the company's dedication to developing and delivering treatments that will make a meaningful difference to people living with migraine. Additional study results focus on data on a new treatment modality for advanced Parkinson's disease as well as new research on carbidopa/levodopa enteral suspension (DUOPA ® ). New data on onabotulinumtoxinA (BOTOX ® ) for the treatment of spasticity and cervical dystonia will also be presented.

"AbbVie's strong presence at AAN reaffirms our unwavering commitment to preserving personhood for people affected by neurological disorders," said Michael Gold , M.D., Therapeutic Area Head, Neuroscience Development, AbbVie. "We're particularly excited about developments and advances across the full spectrum of migraine that demonstrate our innovation and commitment to improving the lives of people with migraine."

Investigators will present data from multiple studies on migraine, including real-world patient-reported outcomes on the effectiveness of ubrogepant (UBRELVY ® ) in those also taking a calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb); a post-hoc analysis that reports the significant magnitude of monthly migraine day reduction in responders to atogepant; and real-world data showing persistence and costs in patients treated with onabotulinumtoxinA or a CGRP mAb.

Researchers will also present six-month interim results from a Phase 3 study on the safety and efficacy of foscarbidopa/foslevodopa (ABBV-951), a levodopa/carbidopa pro-drug administered as a 24-hour continuous, subcutaneous infusion being studied for the treatment of people with advanced Parkinson's disease who are not well controlled on oral medications.

AbbVie abstracts and presentation details for the 2022 AAN Annual Meeting program are outlined below. Posters will be available during and for 30 days following the meeting.

Abstract Title

Presentation Details

All times PST

Migraine

Atogepant – an orally-administered CGRP antagonist – attenuates activation of meningeal nociceptors by Cortical Spreading Depression (CSD)

Oral Presentation (#003)

Wednesday, April 6

3:54 PM

Impact of Monthly Headache Days on Migraine-Related Quality of Life: Results from the CaMEO Study

Oral Presentation (#002)

Sunday, April 3

1:12 PM

Monthly Migraine Days, Acute Medication Use Days, and Migraine-Specific Quality of Life in Responders to Atogepant: A Post Hoc Analysis

Oral Presentation (#008)

Wednesday, April 6

4:54 PM

Characterizing Pre-headache (Prodrome) Features of Migraine Attacks: Results from the CaMEO Study

Oral Presentation (#004)

Sunday, April 3

1:36 PM

Relative Frequency, Healthcare Resource Utilization, and Costs of Diagnosed Drug-Induced Headache and Potential Acute Medication Overuse in Patients with Migraine

Oral Presentation (#009)

Sunday, April 3

2:36 PM

Within-Person Analysis of Ubrogepant Treatment of Mild Versus Moderate-Severe Headache Pain during a Phase 3 Long-Term Safety Extension Trial

Oral Presentation (#006)

Wednesday, April 6

4:30 PM

Evaluation of the Pharmacokinetic Interaction and Safety of Coadministered Atogepant and Topiramate

Poster (#004)

Saturday, April 2

11:45 AM – 12:45 PM

Evaluation of the Long-Term Safety and Tolerability of Oral Atogepant 60 Mg Once Daily for Preventive Treatment of Migraine: A Phase 3, 40-Week, Multicenter Extension to the ADVANCE Trial

Poster (#001)

Saturday, April 2

5:30 PM – 6:30 PM

Post-hoc Analysis of Safety in Phase 3 Atogepant ADVANCE Trial Participants with or without Cardiovascular Disease Risk Factors

Poster (#005)

Saturday, April 2

11:45 AM – 12:45 PM

Atogepant 60 mg Once-Daily Shows Efficacy for the Preventive Treatment of Migraine: Results from a 52-Week Open-Label Extension Trial

Poster (#001)

Saturday, April 2

8:00 AM – 9:00 AM

Decrease in Body Weight with Once-Daily Atogepant for the Preventive Treatment of Migraine: A Post Hoc Analysis

Poster (#002)

Saturday, April 2

8:00 AM – 9:00 AM

Real-World Persistence and Costs Among Patients with Chronic Migraine Treated with OnabotulinumtoxinA or CGRP mAbs: A Retrospective Claims Analysis Study

Poster (#004)

Tuesday, April 5

8:00 AM – 9:00 AM

PREDICT preempt fixed-dose, fixed site and follow the pain

Poster (#003)

Wednesday, April 6

11:45 AM – 12:45 PM

Treatment Satisfaction and Optimization with Real-World Use of Ubrogepant for the Acute Treatment of Migraine in Combination with an Anti-Calcitonin Gene–Related Peptide Monoclonal Antibody Preventive: Results from the COURAGE Study

Poster (#001)

Tuesday, April 5

8:00 AM – 9:00 AM

Within-Person Consistency of Acute Treatment Success with Ubrogepant: Results from a Long-term Safety Study

Poster (#003)

Tuesday, April 5

11:45 AM – 12:45 PM

Real-World Effectiveness of Ubrogepant for the Acute Treatment of Migraine When Used in Combination with an Anti-Calcitonin Gene–Related Peptide Monoclonal Antibody Preventive: Results from the COURAGE Study

Poster (#003)

Tuesday, April 5

8:00 AM – 9:00 AM

Real-World Effectiveness of Ubrogepant Among Participants with Prior Treatment Failure: Subgroup Analysis from the UNIVERSE Study

Poster (#001)

Tuesday, April 5

5:30 PM – 6:30 PM

A Novel Approach to Defining Success in the Acute Treatment of Migraine: Demonstrating Therapeutic Benefit at 1-Hour Post-Dose in the Pooled ACHIEVE I and ACHIEVE II Trials

Poster (#002)

Wednesday, April 6

11:45 AM – 12:45 PM

Advanced Parkinson's Disease

The clinical and humanistic value of "good on-time" among patients with advanced Parkinson's disease: A real-world study from 7 countries

Poster (#005)

Monday, April 4

8:00 AM – 9:00 AM

Safety and Efficacy of 24-Hour/Day Subcutaneous Infusion of Foslevodopa/Foscarbidopa in Advanced Parkinson's Disease During a Phase 3 Study: 6-Month Interim Results

Oral Presentation (#009)

Monday, April 4
5:06 PM

Real-world Effect of Age on Long-term Effectiveness and Safety of Levodopa-Carbidopa Intestinal Gel: A Post Hoc Analysis from the Prospective, Multinational, Observational DUOGLOBE Study

Poster (#007)

Monday, April 4

5:30 PM – 6:30 PM

Long-term Motor and Non-Motor Symptom Benefits in Patients with Advanced Parkinson's Disease Treated with Levodopa-Carbidopa Intestinal Gel by Baseline Hoehn & Yahr Stage: Analysis of the DUOGLOBE Study

Poster

April 24-26

Virtual

Long-term Motor and Non-Motor Symptom Benefits in Patients with Advanced Parkinson's Disease Treated With Levodopa-Carbidopa Intestinal Gel: Final Analysis of the 36-Month DUOGLOBE Real-world Multinational Observational Study

Poster

April 24-26

Virtual

Spasticity

Neutralizing Antibody Conversion with OnabotulinumtoxinA from Global Studies Across Multiple Indications in nearly 30,000 Patient Records: A Meta-Analysis

Oral Presentation (#010)

Sunday, April 3

5:18 PM

Healthcare Resource Utilization and Costs Among Patients with Stroke-related Spasticity Before and After Treatment with OnabotulinumtoxinA

Poster (#006)

Thursday, April 7

8:00 AM – 9:00 AM

Real-world botulinum toxin type A treatment patterns in patients with spasticity

Poster (#004)

Thursday, April 7

11:45 AM – 12:45 PM

A Virtual Reality Platform to Facilitate Training on Treatment of Lower Limb Spasticity with OnabotulinumtoxinA

Oral Presentation (#003)

Wednesday, April 6

3:54 PM

Cervical Dystonia

Impact of Disease Severity on Presentation Subtype and OnabotulinumtoxinA Utilization in Patients with Cervical Dystonia: Results from the CD PROBE Completer Population

Poster (#006)

Thursday, April 7

11:45 AM – 12:45 PM

Current perspectives on the management of cervical dystonia among global clinicians

Poster (#007)

Thursday, April 7

11:45 AM – 12:45 PM

Real-world botulinum toxin type A treatment patterns in patients with cervical dystonia

Poster (#005)

Thursday, April 7

11:45 AM – 12:45 PM

A full list of all 30 AbbVie abstracts accepted for presentation at the 2022 AAN Annual Meeting can be found here .

About ABBV-951
ABBV-951 (foscarbidopa/foslevodopa) is a solution of carbidopa and levodopa prodrugs for continuous subcutaneous infusion that is being investigated for the treatment of advanced Parkinson's disease.

About QULIPTA™ (atogepant)
QULIPTA™, which was approved by the U.S. Food and Drug Administration (FDA) in September 2021 , is available in the United States as the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) specifically developed for the preventive treatment of episodic migraine. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology, and studies have shown that CGRP levels are elevated during migraine attacks. QULIPTA blocks CGRP through a once-daily dose and is available in three strengths – 10 mg, 30 mg and 60 mg.

QULIPTA™ USE AND U.S. IMPORTANT SAFETY INFORMATION

QULIPTA is a prescription medicine used for the preventive treatment of episodic migraine in adults.

Before taking QULIPTA, tell your healthcare provider about all your medical conditions, including if you:

  • Have kidney problems or are on dialysis
  • Have liver problems
  • Are pregnant or plan to become pregnant. It is not known if QULIPTA will harm your unborn baby
  • Are breastfeeding or plan to breastfeed. It is not known if QULIPTA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking QULIPTA

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. QULIPTA may affect the way other medicines work, and other medicines may affect how QULIPTA works. Your healthcare provider may need to change the dose of QULIPTA when taken with certain other medicines.

The most common side effects of QULIPTA are nausea, constipation, and fatigue. These are not all the possible side effects of QULIPTA.

Please see full Prescribing Information .

Globally, prescribing information varies; refer to the individual country product label for complete information.

About UBRELVY ® (ubrogepant)
UBRELVY ® is an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the acute treatment of migraine with or without aura in adults that is an option for a wide range of patients who experience migraine attacks. UBRELVY ® is the first pill of its kind to directly block CGRP, a protein released during a migraine attack, from binding to its receptors.

UBRELVY ® USE AND U.S. IMPORTANT SAFETY INFORMATION

UBRELVY ® is a prescription medicine used for the acute treatment of migraine attacks with or without aura in adults. UBRELVY® is not used to prevent migraine headaches.

Who should not take UBRELVY ® (ubrogepant)?

Do not take UBRELVY ® if you are taking medicines known as strong CYP3A4 inhibitors, such as ketoconazole, clarithromycin, or itraconazole.

What should I tell my healthcare provider before taking UBRELVY ® ?

Tell your healthcare provider about all your medical conditions, including if you:

  • Have liver problems
  • Have kidney problems
  • Are pregnant or plan to become pregnant
  • Are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your healthcare provider can tell you if it is safe to take UBRELVY ® with other medicines.

What are the most common side effects of UBRELVY ® ?
The most common side effects are nausea (4%) and sleepiness (3%). These are not all of the possible side effects of UBRELVY ® .

Please see full Prescribing Information .

Globally, prescribing information varies; refer to the individual country product label for complete information.

About BOTOX ® (onabotulinumtoxinA)
BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Today, BOTOX ® is FDA-approved for 12 therapeutic indications, including chronic migraine, overactive bladder, leakage of urine (incontinence) due to overactive bladder caused by a neurologic condition in adults and in pediatric patients five years of age and older, cervical dystonia, adult and pediatric spasticity, and severe underarm sweating (axillary hyperhidrosis).

BOTOX ® (onabotulinumtoxinA) Important Information

Indications
BOTOX ® is a prescription medicine that is injected into muscles and used:

  • To treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken
  • To treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder caused by a neurologic disease who still have leakage or cannot tolerate the side effects after trying an anticholinergic medication
  • To treat overactive bladder due to a neurologic disease in children 5 years of age and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken
  • To prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older
  • To treat increased muscle stiffness in people 2 years of age and older with spasticity
  • To treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older
  • To treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years of age and older

BOTOX ® is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older.

It is not known whether BOTOX ® is safe and effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).

BOTOX ® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles.

It is not known whether BOTOX ® is safe and effective for severe sweating anywhere other than your armpits.

U.S. IMPORTANT SAFETY INFORMATION
BOTOX ® may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX ® :

  • Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
  • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing

There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX ® has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus.

BOTOX ® may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX ® . If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Do not receive BOTOX ® if you: are allergic to any of the ingredients in BOTOX ® (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc ® (rimabotulinumtoxinB), Dysport ® (abobotulinumtoxinA), or Xeomin ® (incobotulinumtoxinA); have a skin infection at the planned injection site.

Do not receive BOTOX ® for the treatment of urinary incontinence if you: have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing. Due to the risk of urinary retention (not being able to empty the bladder), only patients who are willing and able to initiate catheterization post treatment, if required, should be considered for treatment.

Patients treated for overactive bladder:
In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment with BOTOX ® compared to 2 of the 542 treated with placebo. The median duration of post-injection catheterization for these patients treated with BOTOX ® 100 Units (n = 36) was 63 days (minimum 1 day to maximum 214 days) as compared to a median duration of 11 days (minimum 3 days to maximum 18 days) for patients receiving placebo (n = 2). Patients with diabetes mellitus treated with BOTOX ® were more likely to develop urinary retention than nondiabetics.

Adult Patients treated for overactive bladder due to neurologic disease:
In clinical trials, 30.6% of patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection, required catheterization for urinary retention following treatment with BOTOX ® 200 Units as compared to 6.7% of patients (7/104) treated with placebo. The median duration of post-injection catheterization for these patients treated with BOTOX ® 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days) as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7). Among patients not using CIC at baseline, those with MS were more likely to require CIC post injection than those with SCI.

The dose of BOTOX ® is not the same as, or comparable to, another botulinum toxin product.

Serious and/or immediate allergic reactions have been reported , including itching, rash, red itchy welts, wheezing, asthma symptoms, dizziness, or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX ® should be discontinued.

Tell your doctor about all your muscle or nerve conditions , such as ALS or Lou Gehrig's disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects, including difficulty swallowing and difficulty breathing from typical doses of BOTOX ® .

Tell your doctor if you have any breathing-related problems. Your doctor may monitor you for breathing problems during treatment with BOTOX ® for spasticity or for detrusor overactivity associated with a neurologic condition. The risk of developing lung disease in patients with reduced lung function is increased in patients receiving BOTOX ® .

Cornea problems have been reported. Cornea (surface of the eye) problems have been reported in some people receiving BOTOX ® for their blepharospasm, especially in people with certain nerve disorders. BOTOX ® may cause the eyelids to blink less, which could lead to the surface of the eye being exposed to air more than is usual. Tell your doctor if you experience any problems with your eyes while receiving BOTOX ® . Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch.

Bleeding behind the eye has been reported. Bleeding behind the eyeball has been reported in some people receiving BOTOX ® for their strabismus. Tell your doctor if you notice any new visual problems while receiving BOTOX ® .

Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in adults receiving BOTOX ® for upper limb spasticity. Upper respiratory infections were also reported more frequently in adults with prior breathing-related problems with spasticity. In pediatric patients treated with BOTOX ® for upper limb spasticity, upper respiratory tract infections were reported more frequently. In pediatric patients treated with BOTOX ® for lower limb spasticity, upper respiratory tract infections were not reported more frequently than placebo.

A u t onomic dysreflexia in patients treated for overactive bladder due to neurologic disease. Autonomic dysreflexia associated with intradetrusor injections of BOTOX ® could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in adult patients treated with BOTOX ® 200 Units compared with placebo (1.5% versus 0.4%, respectively).

Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles; trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; have symptoms of a urinary tract infection (UTI) and are being treated for urinary incontinence (symptoms of a urinary tract infection may include pain or burning with urination, frequent urination, or fever); have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX ® can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX ® passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX ® with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX ® in the past.

Tell your doctor if you received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc ® , Dysport ® , or Xeomin ® in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.

Other side effects of BOTOX ® include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, dry eyes; drooping eyebrows; and upper respiratory tract infection. In adults being treated for urinary incontinence, other side effects include urinary tract infection and painful urination. In children being treated for urinary incontinence, other side effects include urinary tract infection and bacteria in the urine. If you have difficulty fully emptying your bladder on your own after receiving BOTOX ® , you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again.

For more information refer to the Medication Guide or talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see BOTOX ® f ull Product Information , including Boxed Warning and Medication Guide .

Globally, prescribing information varies; refer to the individual country product label for complete information.

About DUOPA ® (carbidopa/levodopa)
DUOPA enteral suspension is a prescription medicine used for treatment of advanced Parkinson's disease. DUOPA contains two medicines: carbidopa and levodopa.

U.S. Important Safety Information

What is the most important safety information I should know about DUOPA?

  • Stomach and intestine (gastrointestinal) problems and problems from the procedure you will need to have to receive DUOPA (gastrointestinal procedure-related problems) may occur. Some of these problems may require surgery and may lead to death.
    • Serious side effects may include: a blockage of your stomach or intestines (bezoar); stopping movement through intestines (ileus); drainage, redness, swelling, pain, feeling of warmth around the small hole in your stomach wall (stoma); bleeding from stomach ulcers or your intestines; inflammation of your pancreas (pancreatitis); infection in your lungs (pneumonia); air or gas in your abdominal cavity; skin infection around the intestinal tube, pocket of infection (abscess), or infection in your blood (sepsis) or abdominal cavity may occur after surgery; stomach pain, nausea, or vomiting.
  • Tell your healthcare provider right away if you have any of the following symptoms of stomach and intestine problems and gastrointestinal procedure-related problems: stomach (abdominal) pain; constipation that does not go away; nausea or vomiting; fever; blood in your stool; or a dark tarry stool.

Your healthcare provider will talk to you about the stoma procedure. Before the stoma procedure , tell your healthcare provider if you ever had a surgery or problems with your stomach.

Talk to your healthcare provider about what you need to do to care for your stoma. After the procedure, you and your healthcare provider will need to regularly check the stoma for any signs of infection.

Do not take DUOPA if you currently take or have recently taken (within 2 weeks) a medication for depression called a non-selective monoamine oxidase (MAO) inhibitor. Ask your healthcare provider or pharmacist if you are not sure if you take an MAO inhibitor.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using DUOPA with certain other medicines, including medications for high blood pressure, MAO inhibitors, antipsychotics, metoclopramide, isoniazid, and iron or vitamin supplements, may cause serious side effects. High-protein foods may affect how DUOPA works. Tell your healthcare provider if you change your diet.

DUOPA may cause serious side effects. Talk to your doctor before starting DUOPA and while on DUOPA if you have had or have any of these:

  • Falling asleep during normal daily activities without warning. DUOPA may cause you to fall asleep while you are doing daily activities such as driving, which may result in an accident. This can happen as late as one year after starting DUOPA. Do not drive or operate machinery until you know how DUOPA affects you. Tell your healthcare provider if you take medicines that can make you sleepy, such as sleep medicines, antidepressants, or antipsychotics.
  • Low blood pressure when you stand or sit up quickly. After you have been sitting or lying down, stand up slowly to help reduce dizziness, nausea, sweating, or fainting until you know how DUOPA affects you.
  • Seeing, hearing, or feeling things that are not real (hallucinations).
  • Unusual urges. Some people taking medicines for Parkinson's disease, including DUOPA, have reported urges such as excessive gambling, compulsive eating, compulsive shopping, and increased sex drive.
  • Depression and suicide. DUOPA can cause or worsen depression. Pay close attention to changes in your mood, behavior, thoughts, or feelings. Call your healthcare provider right away if you feel depressed or have thoughts of suicide.
  • Uncontrolled sudden movements (dyskinesia). If you have new dyskinesia or your dyskinesia gets worse, tell your healthcare provider. This may be a sign that your dose of DUOPA or other Parkinson's medicines may need to be adjusted.
  • Progressive weakness or numbness or loss of sensation in the fingers or feet (neuropathy).
  • Heart attack or other heart problems. Tell your healthcare provider if you have experienced increased blood pressure, a fast or irregular heartbeat, or chest pain.
  • Abnormal blood tests. DUOPA may cause changes in certain blood tests, especially certain hormone and kidney function blood tests.
  • Worsening of the increased pressure in your eyes (glaucoma). The pressure in your eyes should be checked after starting DUOPA.

Do not stop using DUOPA or change your dose unless you are told to do so by your healthcare provider. Tell your healthcare provider if you develop withdrawal symptoms such as fever, confusion, or severe muscle stiffness.

The most common side effects of DUOPA include: complications of tubing placement procedure, swelling of legs and feet, nausea, high blood pressure (hypertension), depression, and mouth and throat pain.

Please see the full Prescribing Information , including Medication Guide, for additional information about DUOPA.

Globally, prescribing information varies; refer to the individual country product label for complete information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

About AbbVie in Migraine
At AbbVie, we are committed to empowering people living with migraine disease. We advance science that enables health care providers to care for people impacted across the spectrum of migraine. Through education and partnerships with the migraine community, we strive to help those with migraine navigate barriers to care, access effective treatments and reduce the impact of migraine on their lives.

Our portfolio of therapies, which serves the varying needs of people living with migraine, includes BOTOX ® (onabotulinumtoxinA), the first FDA-approved, preventive treatment for adults with chronic migraine; UBRELVY ® (ubrogepant), the first FDA-approved oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), indicated for the acute treatment of migraine with or without aura in adults; and QULIPTA™ (atogepant), an oral CGRP antagonist for the preventive treatment of episodic migraine in adults.

About AbbVie in Neuroscience
At AbbVie, our commitment to preserve the personhood of those living with neurological and psychiatric disorders is unwavering. Every challenge in this uncharted territory makes us more determined and drives us harder to discover and deliver solutions for patients, care partners and clinicians. AbbVie's Neuroscience portfolio consists of approved therapies in neurological and psychiatric disorders, including bipolar I disorder, major depressive disorder, migraine, Parkinson's disease, post-stroke spasticity, schizophrenia and others along with a robust pipeline.

We have a strong investment in neuroscience research, with our Foundational Neuroscience Center in Cambridge, Massachusetts , and our Neuroscience Discovery site in Ludwigshafen, Germany , where our research and resilience in these challenging therapeutic areas is yielding a deeper understanding of the pathophysiology of neurological and psychiatric disorders, and identifying targets for potential disease-modifying therapeutics aimed at making a difference in people's lives.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

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SOURCE AbbVie

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ABBV
Sirona Biochem Announces Exclusive Global Licensing Agreement with Allergan Aesthetics

Sirona Biochem Announces Exclusive Global Licensing Agreement with Allergan Aesthetics

Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") is pleased to announce it has entered into a global exclusive licensing agreement with Allergan Aesthetics, an AbbVie company (NYSE: ABBV), pursuant to which Allergan Aesthetics will develop and commercialize topical skin care treatments based on active ingredients derived from certain of Sirona's patents for TFC-1067 and related family of compounds.

"We are very pleased to have finalized terms with a global leader in medical aesthetics and the innovator behind SkinMedica™, a leader in the science of skin rejuvenation," said Dr. Howard Verrico, CEO of Sirona Biochem. "Our most recent clinical trial of TFC-1067 was a collaborative effort with Allergan Aesthetics to demonstrate the clinical potential in topical skin care treatments. This further validates our platform technology as viable for additional commercial products which we are actively pursuing. We would like to thank Dr. Linda Pullan of Pullan Consulting who assisted with our current success."

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Biogen and AbbVie Receive Positive Opinion from the CHMP on ZINBRYTA™ (Daclizumab) for Treatment of Multiple Sclerosis

CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.–(BUSINESS WIRE)–The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion
recommending the granting of a marketing authorization for ZINBRYTA™
(daclizumab) intended for the treatment of relapsing forms of multiple
sclerosis (RMS), Biogen
(NASDAQ: BIIB) and AbbVie (NYSE:
ABBV) announced today. ZINBRYTA is a once-monthly, self-administered,
subcutaneous investigational treatment for RMS. ZINBRYTA is also
currently under regulatory review in the United States, Switzerland,
Canada and Australia.
For people with relapsing forms of MS (RMS) and active disease,
ZINBRYTA has the potential to offer robust efficacy, a manageable safety
profile through patient monitoring, and once-monthly subcutaneous
dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and
chief medical officer at Biogen. “ZINBRYTA may offer another option for
people with multiple sclerosis (MS) with its targeted mechanism of
action (MOA) which did not cause broad and prolonged immune cell
depletion.”
The CHMP positive opinion is now referred to the European Commission
(EC), which grants marketing authorizations for centrally authorized
medicines in the European Union. A decision from the EC is expected
within the coming months.
Together with Biogen, AbbVie is committed to meeting the needs of
patients with MS, and the positive opinion issued by the CHMP is a
critical step that moves us closer to bringing ZINBRYTA to patients in
Europe,” said Michael Severino, M.D., executive vice president, research
and development and chief scientific officer, AbbVie.
According to the CHMP opinion, the benefits of ZINBRYTA are its ability
to reduce the annualized relapse rate (ARR), as well as the risk of
24-week confirmed disability progression. The opinion is based on
results from two clinical trials, DECIDE and SELECT, in which ZINBRYTA
150 mg, administered subcutaneously every four weeks improved results on
key measures of MS disease activity in patients with RMS compared to
AVONEX 30 mcg intramuscular injection administered weekly and placebo,
respectively.
In the DECIDE study, the overall incidence of adverse events was similar
in the ZINBRYTA and AVONEX groups. In patients treated with ZINBRYTA
compared to AVONEX, there was an increased incidence of serious
infections (4% versus 2%), serious cutaneous reactions (2% versus <1%),
elevations of liver transaminases greater than five times the upper
limit of normal (6% versus 3%), gastrointestinal disorders (31% versus
24%), and depression (8% versus 6%).
About ZINBRYTA™ (daclizumab)
ZINBRYTA (daclizumab) is an investigational compound being developed for
the treatment of relapsing forms of MS. ZINBRYTA is a new form of a
humanized monoclonal antibody that selectively binds to the
high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is
expressed at high levels on T-cells that become activated in people with
MS. ZINBRYTA modulates IL-2 signaling without general immune cell
depletion.
Biogen and AbbVie are jointly developing ZINBRYTA.
About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops
and delivers worldwide innovative therapies for people living with
serious neurological, autoimmune and rare diseases. Founded in 1978,
Biogen is one of the world’s oldest independent biotechnology companies
and patients worldwide benefit from its leading multiple sclerosis and
innovative hemophilia therapies. For more information, please visit www.biogen.com.
Follow us on Twitter.
Biogen Safe Harbor
This press release contains forward-looking statements, including
statements about the anticipated timing of the EC’s decision on the
marketing authorization for ZINBRYTA, and potential impact of ZINBRYTA,
if approved. These statements may be identified by words such as
“believe,” “expect,” “may,” “potential,” “will” and similar expressions,
and are based on our current beliefs and expectations. You should not
place undue reliance on these statements. Drug development and
commercialization involve a high degree of risk. Factors which could
cause actual results to differ materially from our current expectations
include the risk that the EC may fail to approve or may delay approval
of ZINBRYTA or may not follow the recommendation of the CHMP,
uncertainty of success in commercialization of ZINBRYTA For more
detailed information on the risks and uncertainties associated with our
drug development and commercialization activities and risks relating to
our collaborations with third parties, please review the Risk Factors
section of our most recent annual or quarterly report filed with the
Securities and Exchange Commission. Any forward-looking statements speak
only as of the date of this press release and we assume no obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in
2013 following separation from Abbott Laboratories. The company’s
mission is to use its expertise, dedicated people and unique approach to
innovation to develop and market advanced therapies that address some of
the world’s most complex and serious diseases. Together with its
wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000
people worldwide and markets medicines in more than 170 countries. For
further information on the company and its people, portfolio and
commitments, please visit www.abbvie.com.
Follow @abbvie on
Twitter or view careers on our Facebook or LinkedIn
page.
Forward-Looking Statements
Some statements in this news release may be forward-looking statements
for purposes of the Private Securities Litigation Reform Act of 1995.
The words “believe,” “expect,” “anticipate,” “project” and similar
expressions, among others, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements are
subject to risks and uncertainties that may cause actual results to
differ materially from those indicated in the forward-looking
statements. Such risks and uncertainties include, but are not limited
to, challenges to intellectual property, competition from other
products, difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry.
Additional information about the economic, competitive, governmental,
technological and other factors that may affect AbbVie’s operations is
set forth in Item 1A, “Risk Factors,” in AbbVie’s 2014 Annual Report on
Form 10-K, which has been filed with the Securities and Exchange
Commission. AbbVie undertakes no obligation to release publicly any
revisions to forward-looking statements as a result of subsequent events
or developments, except as required by law.

Enbrel Biosimilar Marks Victory for Merck and Samsung

The biosimilar alliance between Merck (NYSE:MRK) and Samsung Bioepis appears to have paid off, as the companies have won South Korean approval for their copy of Amgen’s (NASDAQ:AMGN) blockbuster drug Enbrel.
According to Fierce Biotech:

Korea’s Ministry of Food and Drug Safety signed off on the injection, to be marketed as Brenzys, to treat rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and psoriasis in adults. The biosimilar, developed as SB4, proved itself equivalent to Amgen’s cash cow in a 596-patient study disclosed this year, reducing symptoms of rheumatoid arthritis on pace with its reference product, according to Merck and Samsung.
Brenzys’ approval marks the first marketing victory for the two companies, a milestone Merck hopes will be a harbinger of future success in biosimilars.
The approval could also have major implications for Samsung Bioepis, long rumored to be considering a U.S. IPO. Details of the company’s Wall Street plans have been tricking out for months, and The Wall Street Journal reported in August that Samsung is planning a $1 billion debut offering for its biologics division, valuing the company at about $7 billion.
Samsung Bioepis, a joint venture with Biogen ($BIIB) that is 85% owned by the South Korean company, joined forces with Merck in 2013 in a wide-ranging deal designed to crack the growing market for off-patent biological treatments. Beyond Enbrel, the pair are working on copies of the similar Humira from AbbVie ($ABBV) and Remicade from Johnson & Johnson ($JNJ). The companies are also developing biosimilars of Sanofi’s ($SNY) blockbuster insulin Lantus and Roche’s ($RHHBY) cancer treatment Herceptin.

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Bristol Myers Squibb Receives Positive CHMP Opinion for Reblozyl® for Adult Patients with Anemia-Associated, Non-Transfusion-Dependent Beta Thalassemia

Approval by the European Commission would expand the indications of Reblozyl for treatment of anemia in adults with beta thalassemia in Europe

In the pivotal BEYOND study, Reblozyl significantly increased hemoglobin levels, which were sustained over longer time compared to placebo

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Bristol Myers Squibb Announces Positive CHMP Opinion for Once-Daily Sotyktu as a Treatment for Adults With Moderate-to-Severe Plaque Psoriasis

CHMP recommendation based on positive results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials and an additional two years of data from the POETYK PSO long-term extension trial

Sotyktu has demonstrated superior efficacy over twice-daily Otezla ® (apremilast) and placebo in improving skin clearance and symptoms

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AMGEN ANNOUNCES WEBCAST OF 2022 FOURTH QUARTER AND FULL YEAR FINANCIAL RESULTS

Amgen (NASDAQ:AMGN) today announced that it will report its fourth quarter and full year 2022 financial results on Tuesday, Jan. 31, 2023 after the close of the U.S. financial markets. The announcement will be followed by a conference call with the investment community at 4:30 p.m. ET . Participating in the call from Amgen will be Robert A. Bradway chairman and chief executive officer, and other members of Amgen's senior management team.

Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

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iVexSol® Closes $23.8M Series A-3 Financing; Funds to Revolutionize the Production of Lentiviral Vectors

IVexSol Inc., a technology-based lentiviral vector (LVV) contract development and manufacturing organization (CDMO), announced $23.8 million in Series A-3 funding. New investors Bristol Myers Squibb (NYSE: BMY), Charles River Laboratories (NYSE: CRL) and Asahi Kasei Medical, a division of Asahi Kasei (NYSE: AHKSY), join existing investors which include Casdin Capital and BioLife Solutions (Nasdaq: BLFS) to close Series A financing at a total of more than $39 million.

The new funding will be used to invest in iVexSol's Intelligent Vector Solutions by advancing process and analytical technologies, expanding technical teams in Quality, Regulatory and cGMP operations, and augmenting existing infrastructure to support the production of stable LVV producer cell lines.

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Bristol Myers Squibb Announces TRANSCEND CLL 004 Trial of Breyanzi® Met Primary Endpoint of Complete Response Rate in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia

Bristol Myers Squibb (NYSE: BMY) today announced topline results from TRANSCEND CLL 004, a Phase 1/2, open-label, single-arm, multicenter study evaluating Breyanzi (lisocabtagene maraleucel) in adults with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Results from TRANSCEND CLL 004 showed the study met the primary endpoint of complete response rate compared to historical control in the prespecified subset of patients with R/R CLL that was refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor. No new safety signals were reported for Breyanzi in this study.

"CLL is an incurable disease with complex biology and immune dysregulation that has made the development of T cell-based therapies that provide deep remission very challenging," said Anne Kerber, senior vice president, head of Cell Therapy Development, Bristol Myers Squibb. "In a population that has limited options, the TRANSCEND CLL 004 study represents the first multicenter trial evaluating a CAR T cell therapy in heavily pre-treated patients with relapsed or refractory CLL or SLL, with results showing the potential of Breyanzi as a personalized one-time treatment approach for patients with this difficult-to-treat disease."

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Aurinia Announces PTAB Has Terminated Inter Partes Review

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia) announces that the Patent Trial and Appeal Board (PTAB) of the United States' Patent and Trademark Office has terminated the Inter Partes Review (IPR) it had instituted with respect to Aurinia's U.S. Patent No. 10,286,036.

About LUPKYNIS
LUPKYNIS is the first FDA-approved oral therapy for LN. LN causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. It is one of the most serious and common complications of the autoimmune disease systemic lupus erythematosus (SLE). LUPKYNIS is in the United States (U.S.) and across the European Union (E.U).

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