Life Science News

ABBVie today announced the U.S. Food and Drug Administration has approved RINVOQ ® for the treatment of moderate to severe atopic dermatitis in adults and children 12 years of age and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended. 1 RINVOQ 15 mg once daily ...

ABBVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved RINVOQ ® (upadacitinib) for the treatment of moderate to severe atopic dermatitis in adults and children 12 years of age and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended. 1 RINVOQ 15 mg once daily can be initiated in adults and children 12 years of age and older weighing at least 40 kg. 1 In these children and adults less than 65 years of age who do not achieve an adequate response, the dose may be increased to 30 mg once daily. 1

"Early in my career as an allergist, I saw how relentless the itch and rash could be for my patients with moderate to severe atopic dermatitis yet had limited options to offer those whose disease could not be adequately controlled with systemic therapy," said Thomas Hudson , M.D., senior vice president, research and development, chief scientific officer, AbbVie. "This additional approval for RINVOQ provides a once-daily oral option that can significantly improve the debilitating itch and skin symptoms of atopic dermatitis. It's also a proud moment for AbbVie as we continue our efforts to improve care in this disease state and other chronic, immune-mediated conditions."

The FDA approval is supported by efficacy and safety data from one of the largest registrational Phase 3 programs for atopic dermatitis with more than 2,500 patients evaluated across three studies. Approximately 52 percent of the patients had prior exposure to systemic atopic dermatitis treatment. These studies evaluated the efficacy and safety of RINVOQ monotherapy (Measure Up 1 and 2) and with topical corticosteroids (AD Up), compared to placebo, in adults and children 12 years of age and older with moderate to severe atopic dermatitis. 2-3

"Despite available therapies, many people with moderate to severe atopic dermatitis are caught in an endless cycle of itching and scratching," said Emma Guttman-Yassky , M.D., Ph.D., Waldman Professor and System Chair of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City .* "In clinical trials, upadacitinib showed a robust response across skin and itch symptoms that may help evolve treatment goals for those who have not achieved adequate control of their disease. And as an oral pill with two dose strengths, upadacitinib is a welcome addition to the toolbox of clinicians who are striving to make a significant difference for their patients with moderate to severe atopic dermatitis."

Clinical Response at Week 16 1-3

  • Across the three atopic dermatitis pivotal studies, RINVOQ (15 mg and 30 mg, once daily) monotherapy and with topical corticosteroids met all primary and secondary endpoints at week 16, with some patients achieving higher levels of skin clearance (EASI 90 and 100).

Week 16 Data


Measure Up 1 (MU1)

Measure Up 2 (MU2)

AD Up (AU)


RINVOQ
15 mg

(n=281)

RINVOQ
30 mg

(n=285)

Placebo

(n=281)

RINVOQ
15 mg

(n=276)

RINVOQ
30 mg

(n=282)

Placebo


(n=278)

RINVOQ
15 mg
plus TCS

(n=300)

RINVOQ
30 mg
plus TCS

(n=297)


Placebo
plus TCS

(n=304)

EASI 75*

70%

80%

16%

60%

73%

13%

65%

77%

26%

vIGA-AD 0/1*

48%

62%

8%

39%

52%

5%

40%

59%

11%

EASI 90

53%

66%

8%

42%

58%

5%

43%

63%

13%

EASI 100

17%

27%

2%

14%

19%

1%

12%**

23%

1%

Worst Pruritus NRS ≥4

52%

60%

12%

42%

60%

9%

52%

64%

15%

*Co-primary endpoints were EASI 75 and vIGA-AD 0/1 at week 16. Not all secondary endpoints are shown.

**Endpoint not controlled for multiplicity.

EASI 75 is defined as at least a 75 percent reduction in Eczema Area and Severity Index. EASI 90 and 100 are defined as at least 90 percent or 100 percent reduction in Eczema Area and Severity Index.

vIGA-AD 0/1 is defined as a validated Investigator Global Assessment for Atopic Dermatitis of clear or almost clear (0/1) with at least two grades of reduction from baseline.

Worst Pruritus NRS ≥4 is defined as the proportion of subjects achieving an improvement in Worst Pruritus Numerical Rating Scale (NRS) ≥4 for subjects with Worst Pruritus NRS score ≥4 at baseline.

Itch Reduction 1-3

  • In all three studies, a significant improvement in itch (Worst Pruritus NRS ≥4) was observed as early as week one, compared to placebo.

Safety 1-3

  • Overall, the safety profile observed in patients with atopic dermatitis treated with RINVOQ 15 mg or 30 mg was similar to the safety profile observed in patients with rheumatoid arthritis. Other specific adverse reactions reported in atopic dermatitis patients included eczema herpeticum/Kaposi's varicelliform eruption.
  • RINVOQ may cause serious side effects, including:
    • Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.
    • Increased risk of death in people 50 years and older with at least 1 heart disease (cardiovascular) risk factor.
    • Cancer and immune system problems. RINVOQ may increase your risk of certain cancers, including lymphoma, skin, and lung cancer, as these can happen. Current or past smokers are at higher risk.
    • Increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50 years and older with at least 1 heart disease (cardiovascular) risk factor, especially in current or past smokers.
    • Blood clots. Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. This has happened more often in people 50 years and older with at least 1 heart disease (cardiovascular) risk factor.

Do not take RINVOQ if you are allergic to upadacitinib or any of the ingredients in RINVOQ.

Other serious side effects include serious allergic reactions, tears in the stomach or intestines and changes in certain laboratory test results.

Patient Access and Support
AbbVie is committed to helping people access RINVOQ and other medicines, including offering a patient support program and a co-pay card that may reduce out-of-pocket costs to as little as $5 per month for eligible, commercially-insured patients. For those with limited or no health insurance, AbbVie offers myAbbVie Assist, a patient assistance program that provides RINVOQ at no charge to those who qualify. More information about this assistance program can be found on www.AbbVie.com/myAbbVieAssist .

The Impact of Atopic Dermatitis
Atopic dermatitis is a chronic, relapsing inflammatory condition characterized by a cycle of intense itching and scratching that leads to cracked, scaly and oozing skin. 4-6 It affects an estimated 7 percent of adults and 12 percent of adolescents in the U.S., with approximately 40 percent of adults experiencing moderate to severe disease. 7-8 It manifests differently across individuals, with symptoms posing significant physical, psychological and economic burdens. 4-5,9

"Every person with atopic dermatitis has a unique experience with their disease, and in turn, must have multiple options to choose from in their journey to find a treatment that meets their individual needs," said Julie Block , president and chief executive officer, National Eczema Association. "This approval is a significant milestone for our community, providing an additional therapy that may bring relief to those living with the devastating symptoms of moderate to severe atopic dermatitis."

About RINVOQ ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a selective JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. 10 Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2. 1 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.

In the U.S., RINVOQ 15 mg and 30 mg is approved for use in adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable. 1 RINVOQ 15 mg is also approved in the U.S. for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers as well as adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. In the EU, RINVOQ 15 mg is approved for the treatment of adults with moderate to severe active rheumatoid arthritis, adults with active psoriatic arthritis and adults with active ankylosing spondylitis. RINVOQ is also approved in the EU for adults (15 mg and 30 mg) and adolescents (15 mg) with moderate to severe atopic dermatitis.

Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing. 11-18

RINVOQ ® (upadacitinib) U.S. Use and Important Safety Information 1

RINVOQ is a prescription medicine used to treat:

  • Adults with moderate to severe rheumatoid arthritis when 1 or more tumor necrosis factor (TNF) blockers have been used and did not work well or could not be tolerated.
  • Adults with active psoriatic arthritis when 1 or more tumor necrosis factor (TNF) blockers have been used and did not work well or could not be tolerated.

It is not known if RINVOQ is safe and effective in children under 18 years of age with juvenile idiopathic arthritis or psoriatic arthritis.

  • Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis) who did not respond to previous treatment and whose eczema is not well controlled with other pills or injections, including biologic medicines, or when the use of other pills or injections is not recommended.

RINVOQ is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis.

It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.

What is the most important information I should know about RINVOQ?

RINVOQ may cause serious side effects, including:

  • Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You should not start taking RINVOQ if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster).
  • Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor.
  • Cancer and immune system problems. RINVOQ may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer.  Follow your HCP's advice about having your skin checked for skin cancer during treatment with RINVOQ. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen.
  • Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker.
  • Blood clots. Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor.
  • Allergic reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking RINVOQ. Some of these reactions were serious. If any of these symptoms occur during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help right away.
  • Tears in the stomach or intestines and changes in certain laboratory tests. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results.

Do not take RINVOQ if:

  • You are allergic to upadacitinib or any of the ingredients in RINVOQ.

What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:

  • Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection such as:
    • Fever, sweating, or chills
    • Shortness of breath
    • Warm, red, or painful skin or sores on your body
    • Muscle aches
    • Feeling tired
    • Blood in phlegm
    • Diarrhea or stomach pain
    • Cough
    • Weight loss
    • Burning when urinating or urinating more often than normal
  • Have TB or have been in close contact with someone with TB.
  • Are a current or past smoker.
  • Have had a heart attack, other heart problems, or stroke.
  • Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.
  • Have other medical conditions including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.
  • Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of areas, ask your HCP.
  • Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines.
  • Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant during treatment with RINVOQ and for 4 weeks after your last dose.
  • Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. Do not breastfeed during treatment with RINVOQ and for 6 days after your last dose.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.

Especially tell your HCP if you take:

  • Medicines for fungal or bacterial infections
  • Rifampicin or phenytoin
  • Medicines that affect your immune system

If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist.

What should I do or tell my HCP AFTER starting RINVOQ?

  • Tell your HCP right away if you have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse
  • Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, including:
    • Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back
    • Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
    • Pain or discomfort in your arms, back, neck, jaw, or stomach
    • Shortness of breath with or without chest discomfort
    • Breaking out in a cold sweat
    • Nausea or vomiting
    • Feeling lightheaded
    • Weakness in one part or on one side of your body
    • Slurred speech
  • Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with RINVOQ, including:
    • Swelling
    • Pain or tenderness in one or both legs
    • Sudden unexplained chest or upper back pain
    • Shortness of breath or difficulty breathing
  • Tell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits.

What are the common side effects of RINVOQ?
These include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections, including cold sores, bronchitis, nausea, cough, fever, acne, headache, increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, low white blood cell count (neutropenia), muscle pain, and flu-like illness.

Separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with RINVOQ. Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ.

These are not all the possible side effects of RINVOQ.

How should I take RINVOQ?
RINVOQ is taken once a day with or without food. Do not split, break, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg and 30 mg extended-release tablets.

This is the most important information to know about RINVOQ. For more information, talk to your HCP.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://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.

Please click here for the Full Prescribing Information and Medication Guide .

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

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 , LinkedIn or Instagram .

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 of AbbVie's acquisition of Allergan plc ("Allergan"), failure to 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 2020 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.

* Emma Guttman-Yassky , M.D., Ph.D., is a researcher/consultant for AbbVie.

References:

  1. RINVOQ ® (upadacitinib) [Package Insert]. North Chicago, Ill. : AbbVie Inc.
  2. Guttman-Yassky E ., et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021; 397(10290): 2151-2168. doi:10.1016/S0140-6736(21)00588-2.
  3. Reich, Kristian et al. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021; 397(10290): 2169 – 2181. doi:10.1016/S0140-6736(21)00589-4.
  4. Nutten S. Atopic Dermatitis: Global Epidemiology and Risk Factors. Ann Nutr Metab 2015;66(suppl 1):8–16.
  5. Weidinger S., et al. Atopic dermatitis. Nat Rev Dis Primers 4, 1 (2018). https://doi.org/10.1038/s41572-018-0001-z .
  6. University of Michigan Medicine. Atopic Dermatitis (Eczema). 2020. Available at: https://www.uofmhealth.org/health-library/hw216104#hw216107. Accessed on December 10, 2021 .
  7. Silverberg JI. Public Health Burden and Epidemiology of Atopic Dermatitis. Dermatol Clin. 2017;35(3):283-289.
  8. Chiesa Fuxench ZC, Block JK, Boguniewicz M, et al. Atopic Dermatitis in America Study : A Cross-Sectional Study Examining the Prevalence and Disease Burden of Atopic Dermatitis in the US Adult Population. J Invest Dermatol. 2019;139(3):583-590.
  9. Eichenfield L.F., et al. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70(2):338-351. doi:10.1016/j.jaad.2013.10.010.
  10. Pipeline – Our Science | AbbVie. AbbVie. 2019. Available at: https://www.abbvie.com/our-science/pipeline.html . Accessed on December 10, 2021 .
  11. A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone (SELECT-NEXT). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02675426. Accessed on December 10, 2021.
  12. Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema) (Measure Up 1). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03569293. Accessed on December 10, 2021.
  13. A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT - PsA 1). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed on December 10, 2021.
  14. A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373. Accessed on December 10, 2021.
  15. A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03345836. Accessed on Accessed on December 10, 2021.
  16. A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on December 10, 2021.
  17. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on December 10, 2021.
  18. A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04161898. Accessed on December 10, 2021.

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ABBV

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
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Additional information about the economic, competitive, governmental,
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set forth in Item 1A, “Risk Factors,” in AbbVie’s 2014 Annual Report on
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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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Boosh Launches AMUSE BOOSH Appetizer Line

Boosh Launches AMUSE BOOSH Appetizer Line

Boosh Plant-Based Brands Inc. (CSE: VEGI) (OTCQB: VGGIF) (FSE: 77I) ("Boosh" or the "Company") is proud to announce the launch of their appetizer line "Amuse Boosh".

Inspired by the French term Amuse-bouche, which refers to a small appetizer and literally translated means "mouth amuser" it is a perfect way to spotlight our recently acquired brands Saltspring Harvest Végé-pâté and Dips, and Pulse Kitchen Plant Based Cheese under one fun, vibrant Boosh Brand.

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BioHarvest Sciences Inc. Plans to Build a Production Facility in Ontario to Serve the Canadian Market with Unique Cannabis Products

BioHarvest Sciences Inc. Plans to Build a Production Facility in Ontario to Serve the Canadian Market with Unique Cannabis Products

The Company is now producing Cannabis in industrial scale bioreactors and has entered the final stage of its Cannabis commercialization program

BioHarvest Sciences Inc. (CSE: BHSC) ("BioHarvest" or the "Company") has announced its plan to build a production facility in Canada, as part of the next phase in the global expansion of its Cannabis vertical. To that end, the Company is exploring opportunities to acquire an existing licensed facility or a Licensed Producer (LP), which would enable the Company to use its BioFarming technology to produce and then sell unique cannabis products into the Canadian market.

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LUMAKRAS® RECEIVES APPROVAL IN JAPAN FOR PATIENTS WITH KRAS G12C-MUTATED ADVANCED NON-SMALL CELL LUNG CANCER

Amgen (NASDAQ: AMGN) today announced that LUMAKRAS ® (sotorasib) has been approved in Japan for the treatment of KRAS G12C-mutated positive, unresectable, advanced andor recurrent non-small cell lung cancer (NSCLC) that has progressed after systemic anticancer therapy.

"Today's approval of LUMAKRAS as the first and only KRAS G12C inhibitor marks a paradigm shift in the treatment of patients with non-small cell lung cancer in Japan ," said David M. Reese , M.D., executive vice president of Research and Development at Amgen. "In just over three years since the first patient was dosed in the pivotal CodeBreaK 100 trial, LUMAKRAS is now approved in nearly 40 countries, illustrating our commitment to accelerating transformative medicines for patients living with cancers that have yet to be fully addressed."

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BriaCell Therapeutics Corp. Announces Results of 2022 Annual and Special Meeting of Shareholders

BriaCell Therapeutics Corp. Announces Results of 2022 Annual and Special Meeting of Shareholders

BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company") is pleased to announce that all resolutions proposed to shareholders at the Annual and Special Meeting of Shareholders (the "Meeting" ) held virtually via teleconference on January 18, 2022 were passed. Voting for each of the director nominees was as follows:

Nominee
For Withheld
Actual Percentage Actual Percentage
Dr. William V. Williams 2,286,353 97.68% 54,346 2.32%
Mr. Jamieson Bondarenko 2,286,214 97.67% 54,485 2.33%
Mr. Marc Lustig 2,285,435 97.64% 55,263 2.36%
Dr. Rebecca Taub 2,327,126 99.42% 13,573 0.58%
Mr. Vaughn C. Embro-Pantalony 2,285,426 97.64% 55,273 2.36%
Mr. Martin Schmieg 2,326,345 99.39% 14,353 0.61%
Dr. Jane Gross 2,327,674 99.44% 13,024 0.56%

Shareholders also voted in favour of: (i) setting the number of directors for the ensuing year at seven; (ii) re-appointing MNP LLP as auditors of the Company; (iii) approving the Company's stock option plan; and (iv) approving an amendment to the authorized share structure and articles of the Company by creating a new class of subordinate voting shares, and to vary the special rights and restrictions attached to the Common Shares to reflect the creation of the new class of shares, as more particularly described in the Company's Management Information Circular dated December 20, 2021 and posted to SEDAR on January 4, 2022. Please see the report of voting results filed under BriaCell's profile at www.sedar.com for the detailed results of these other matters voted on by shareholders at the Meeting.

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Cardiol Therapeutics Appoints Thought Leaders in Cardiovascular Medicine to its Scientific Advisory Board

Cardiol Therapeutics Appoints Thought Leaders in Cardiovascular Medicine to its Scientific Advisory Board

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory therapies for the treatment of cardiovascular disease, today announced the appointment of Paul M. Ridker, MD, MPH, Bruce McManus, PhD, MD, and Joseph A. Hill, MD, PhD, to its Scientific Advisory Board (SAB).

"We are pleased to welcome distinguished thought leaders in cardiovascular medicine to our Scientific Advisory Board," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics. "Their expertise in cardiovascular research will provide invaluable guidance to our research and clinical programs focused on the development of novel anti-inflammatory therapies for the treatment of heart disease."

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Gilead Sciences to Release Fourth Quarter & Full Year 2021 Financial Results on Tuesday, February 1, 2022

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its fourth quarter and full year 2021 financial results will be released on Tuesday, February 1, after the market closes. At 4:30 p.m. Eastern Time that day, Gilead's management will host a webcast to discuss the company's fourth quarter and full year 2021 financial results and will provide a business update.

A live webcast will be available on the investor relations page of http://investors.gilead.com and will be archived on www.gilead.com for one year.

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