Life Science News

  • In patients with moderate to severe Crohn's disease who achieved clinical response to u padacitinib induction treatment, a significantly greater proportion treated with either 15 mg or 30 mg of upadacitinib achieved clinical remission, a,b endoscopic response c and endoscopic remission d at week 52 compared to placebo
  • The safety results in this study were generally consistent with the known profile of upadacitinib, with no new safety risks observed
  • Upadacitinib, a JAK inhibitor discovered and developed by AbbVie, is being studied as an oral therapy for moderate to severe Crohn's disease and several other immune-mediated diseases

AbbVie today announced positive topline results from U-ENDURE, its Phase 3 maintenance study evaluating upadacitinib in adult patients with moderate to severe Crohn's disease who had an inadequate response or were intolerant to a conventional or biologic therapy. The results showed that more patients treated with either dose of upadacitinib (15 mg or 30 mg once daily) achieved the co-primary endpoints of endoscopic response and clinical remission, as well as the secondary endpoint of endoscopic remission, at one year (week 52) compared to placebo. 1 Use of upadacitinib in Crohn's disease has not been evaluated by health authorities. Results from the U-ENDURE maintenance study, in addition to results from the U-EXCEED and U-EXCEL induction studies, will be included in future regulatory submissions.

In the U-ENDURE maintenance study, patients from U-EXCEED and U-EXCEL who responded to 12 weeks of upadacitinib 45 mg oral induction treatment were re-randomized to receive upadacitinib 15 mg, upadacitinib 30 mg, or placebo. Clinical remission was defined by the Crohn's Disease Activity Index (CDAI) or by stool frequency and abdominal pain score (SF/AP).

A significantly higher proportion of patients who received upadacitinib 15 mg or 30 mg achieved clinical remission per the CDAI at week 52: 37 and 48 percent, respectively, versus 15 percent in the placebo group (p 1 Results also showed that 36 and 46 percent of patients who received upadacitinib 15 mg and 30 mg, respectively, achieved clinical remission at week 52 per SF/AP compared to 14 percent in the placebo group (p 1 At week 52, 28 and 40 percent of patients who received upadacitinib 15 mg and 30 mg, respectively, achieved endoscopic response compared to 7 percent of patients who received placebo (p 1 In addition, 19 and 29 percent of patients who received upadacitinib 15 mg and 30 mg achieved endoscopic remission, respectively, compared to 5 percent of patients in the placebo group (p 1 A significantly higher proportion of patients who received upadacitinib 15 mg or 30 mg achieved corticosteroid-free clinical remission per CDAI and per SF/AP compared to placebo at week 52 among patients taking corticosteroids at baseline. 1

"We are deeply committed to supporting Crohn's disease patients who continue to live with challenging symptoms that impact their daily lives," said Thomas Hudson , M.D., senior vice president, research and development, chief scientific officer, AbbVie. "These results represent important progress as we work to bring new treatment options to patients with inflammatory bowel disease."

"Symptomatic relief as well as healing of the intestinal mucosa in Crohn's disease are important long-term treatment targets which may be associated with slowing disease progression and better quality of life for patients," said Julian Panes , Emeritus Professor of Medicine and the Chief of the IBD Unit at Hospital Clínic de Barcelona and lead study investigator. "These results are encouraging and would be particularly important for patients who have not found relief with other conventional or biologic treatment options."

Efficacy Results at Week 52


Placebo

(n = 165)

Upadacitinib 15 mg

(n = 169)

Upadacitinib 30 mg

(n = 168)

Clinical Remission

(per CDAI) a

15%

37%*

48%*

Clinical Remission

(per SF/AP) b

14%

36%*

46%*

Endoscopic Response c

7%

28%*

40%*

Endoscopic Remission d

5%

19%*

29%*

Co- primary endpoints were clinical remission (per CDAI for the U.S. FDA and per SF/AP for the EU EMA) and endoscopic response at week 52.

ꝉ Efficacy was assessed after the first 502 patients reached week 52.

* Statistically significant with p-values of

a Clinical remission per CDAI is defined as CDAI

b Clinical remission per SF/AP is defined as average daily very soft or liquid stool frequency ≤2.8 AND average daily abdominal pain score ≤1.0, and both not greater than baseline .

c Endoscopic response is defined as a decrease in Simplified Endoscopic Score for Crohn's disease (SES-CD) of >50 percent from baseline (or at least a 2-point reduction from baseline for patients with a baseline SES-CD of 4), as scored by central reviewer.

d Endoscopic remission is defined as SES-CD ≤ 4 and at least a 2-point reduction from baseline and no subscore > 1 in any individual variable, as scored by central reviewer.

The safety results of upadacitinib (15 mg or 30 mg) were generally consistent with the safety profile observed in the Phase 3 induction studies in Crohn's disease, as well as the known safety profile of upadacitinib. No deaths were reported throughout the study and no new safety risks were identified.

A total of 673 patients completed the 12-week upadacitinib induction treatment with clinical response and received at least one dose of the study drug in the placebo-controlled maintenance period. The most common adverse events in the upadacitinib groups were exacerbation of Crohn's disease, arthralgia and pyrexia. 1 Serious adverse event and serious infection event rates per 100 patient years were the following for placebo, upadacitinib 15 mg, and upadacitinib 30 mg groups, respectively: 37.4/8.4, 25.0/6.1, 21.0/7.8. Malignancies (excluding non-melanoma skin cancer [NMSC]) reported in the study included one event in the upadacitinib 15 mg group, two events in the upadacitinib 30 mg group and no events in the placebo group. 1 No adjudicated thrombotic events were reported in the upadacitinib 15 mg and placebo groups; one adjudicated hepatic vein thrombosis was reported in the upadacitinib 30 mg group. 1 No adjudicated major adverse cardiovascular event (MACE) was reported in any treatment group. 1 One patient each in the upadacitinib 15 mg, 30 mg and placebo groups experienced an event of adjudicated gastrointestinal perforation. 1

The U-ENDURE Phase 3 study was designed to evaluate the efficacy and safety of upadacitinib as maintenance therapy versus placebo in patients with moderate to severe Crohn's disease who responded to upadacitinib induction treatment in the U-EXCEED or U-EXCEL induction studies. Full results from the U-ENDURE study maintenance period will be presented at upcoming medical conferences and published in a peer-reviewed medical journal. Use of upadacitinib in Crohn's disease is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

About Crohn's Disease

Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal (or digestive) tract, causing persistent diarrhea and abdominal pain. 2,3 It is a progressive disease, meaning it gets worse over time in a substantial proportion of patients or may develop complications that require urgent medical care including surgery. 2,3 Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease—not only physically, but also emotionally and economically. 2

About U-ENDURE

The U-ENDURE study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled maintenance and long-term study designed to evaluate the efficacy and safety of upadacitinib 15 mg and 30 mg in adults with moderate to severe Crohn's disease. U-ENDURE enrolled patients who responded to 12 weeks of induction treatment from the U-EXCEED and U-EXCEL studies. In addition to the double-blind, placebo-controlled component, the U-ENDURE study also included patients from the induction studies who either responded to placebo or to extended treatment (an additional 12 weeks with 30 mg upadacitinib). During the study, patients who lost response were eligible to receive 30 mg upadacitinib as rescue therapy.

The study included slightly different sets of primary and secondary endpoints for the U.S. Food and Drug Administration (FDA) and the EU European Medicines Agency (EMA). The primary endpoints were achievement of clinical remission (per CDAI for the U.S. FDA, and per SF/AP for the EU EMA, which was measured by average daily very soft or liquid stool frequency and abdominal pain score) and endoscopic response (per SES-CD) at week 52. More information can be found on www.clinicaltrials.gov (NCT03345823).

About the Upadacitinib Phase 3 Crohn's Disease Program 4, 5, 6

The global upadacitinib Phase 3 program evaluates more than 1,000 patients with moderate to severe Crohn's disease across two induction studies and a maintenance study. These studies include assessments of efficacy, safety and tolerability of upadacitinib. More information on these trials can be found at www.clinicaltrials.gov (NCT03345836, NCT03345849, NCT03345823).

About Upadacitinib (RINVOQ ® )

Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. 7 -14 Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK1 vs JAK2, JAK3, and TYK2. 14 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.

Phase 3 trials of RINVOQ in rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis, ulcerative colitis, giant cell arteritis, Takayasu arteritis and vitiligo are ongoing. 7 - 14 The use of upadacitinib in Crohn's disease is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

RINVOQ ® (upadacitinib) U.S. Use and Important Safety Information 14

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.
  • Adults with moderate to severe ulcerative colitis when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
  • Adults with active ankylosing spondylitis when 1 or more medicines called 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 with juvenile idiopathic arthritis, psoriatic arthritis, ulcerative colitis, or ankylosing spondylitis.

  • Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis) that 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 other possible side effects of RINVOQ?

Common side effects 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, lower number of certain types of white blood cells (neutropenia, lymphopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, and increased liver enzyme levels.

A 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, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg, 30 mg, and 45 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 in Gastroenterology

With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. For more information on AbbVie in gastroenterology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html .

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 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.

1 AbbVie. Data on File: ABVRRTI73939
2 The Facts about Inflammatory Bowel Diseases. Crohn's & Colitis Foundation of America. 2014. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf . Accessed on January 11, 2022.
3 Crohn's disease. Symptoms and Causes. Mayo Clinic. 2022. Available at: https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304 . Accessed on January 11, 2022.
4 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 Conventional and/or Biologic Therapies. ClinicalTrials.gov. 2022. Available at: https://clinicaltrials.gov/ct2/show/NCT03345849 . Accessed on January 11, 2022.
5 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. 2022. Available at: https://clinicaltrials.gov/ct2/show/NCT03345836 . Accessed on January 11, 2022.
6 A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433. ClinicalTrials.gov. 2022. Available at: https://clinicaltrials.gov/ct2/show/NCT03345823 . Accessed on January 11, 2022.
7 Pipeline – Our Science | AbbVie. AbbVie. 2022. Available at: https://www.abbvie.com/our-science/pipeline.html . Accessed on January 11, 2022.
8 A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. 2022. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373 . Accessed on January 11, 2022.
9 A Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2022. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635 . Accessed on January 11, 2022.
10 A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis (Heads Up). ClinicalTrials.gov. 2022. Available at: https://clinicaltrials.gov/ct2/show/NCT03738397 . Accessed on January 11, 2022.
11 A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis (U-ACCOMPLISH). ClinicalTrials.gov. 2022. Available at: https://clinicaltrials.gov/ct2/show/NCT03653026 . Accessed on January 11, 2022.
12 A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2022. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202 . Accessed on January 11, 2022.
13 A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. 2022. Available at: https://clinicaltrials.gov/ct2/show/NCT04161898 . Accessed on January 11, 2022.
14 RINVOQ ® (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.

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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
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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The Klein Law Firm Reminds Investors of Class Actions on Behalf of Shareholders of IBM, MYPS and AUPH

The Klein Law Firm announces that class action complaints have been filed on behalf of shareholders of the following companies. There is no cost to participate in the suit. If you suffered a loss, you have until the lead plaintiff deadline to request that the court appoint you as lead plaintiff

International Business Machines Corporation (NYSE:IBM)
Class Period: April 4, 2017 - October 20, 2021
Lead Plaintiff Deadline: June 6, 2022

Throughout the class period, International Business Machines Corporation allegedly made materially false and/or misleading statements and/or failed to disclose that: (i) Strategic Imperatives Revenue and growth, CAMSS and CAMSS Components' revenue and growth, and the Company's Segments' revenue and growth were artificially inflated as a result of the wrongful reclassification of revenues from non-strategic to strategic to make those revenues eligible for treatment as Strategic Imperatives Revenue; (ii) the Company's present success and positive future growth prospects concerning its Strategic Imperative business strategy were being fueled by the wrongful reclassification of revenues from non-strategic to strategic to make those revenues eligible for treatment as Strategic Imperative Revenue and, as a result (iii) the Company misled the market by portraying the Company's Strategic Imperative's financial performance and future prospects more favorable than they actually were as a result of the wrongful reclassification of revenues from non-strategic to strategic to make those revenues eligible for treatment as Strategic Imperatives.

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The Gummy Project

Potent Ventures Announces The Gummy Project Selected by Sweets & Snack Expo Committee to Participate in Power Pitch During Sweets & Snacks Expo

Potent Ventures Inc. (CSE: POT) (FSE: 0OS) (OTCQB: POTVF) ("Potent" or the "Company") is pleased to announce that The Gummy Project is one of two companies selected from the show's Startup Street to participate in Power Pitch at Sweets & Snacks Expo on May 24, 2022.

Power Pitch provides selected companies with an opportunity to showcase their products in a sales pitch-style presentation to a panel of leading US retailers, including the following:

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The Gross Law Firm Announces Class Actions on Behalf of Shareholders of ABBV, UPST and AXSM

The securities litigation law firm of The Gross Law Firm issues the following notice on behalf of shareholders in the following publicly traded companies. Shareholders who purchased shares in the following companies during the dates listed are encouraged to contact the firm regarding possible Lead Plaintiff appointment. Appointment as Lead Plaintiff is not required to partake in any recovery

ABBVie Inc. (NYSE:ABBV)

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Gilead and Kite Oncology to Highlight Advances Supporting New Innovations in Cancer Care at the ASCO Annual Meeting

Late-Breaking TROPiCS-02 Study Results in Heavily Pre-Treated HR+HER2- Metastatic Breast Cancer Patients to be Featured in ASCO Press Program –

New Sub-Analysis from Kite's ZUMA-7 CAR T-cell Therapy Study in Patients Aged 65+ and Data by Tumor Burden Characteristics in Second-Line Large B-cell Lymphoma to be Presented

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Investor Reminder: Kessler Topaz Meltzer & Check, LLP Reminds Investors of Deadline in Securities Fraud Class Action Lawsuit Filed Against AbbVie, Inc.

The law firm of Kessler Topaz Meltzer & Check, LLP(www.ktmc.com) informs investors that the firm has filed a securities class action lawsuit against ABBVie, Inc. (ABBVie) (NYSE:ABBV) on behalf of all persons and entities who purchased or otherwise acquired ABBVie securities between April 30, 2021, and August 31, 2021, inclusive (the "Class Period

CLICK HERE TO SUBMIT YOUR ABBVIE LOSSES. YOU CAN ALSO CLICK ON THE FOLLOWING LINK OR COPY AND PASTE IN YOUR BROWSER: https://www.ktmc.com/new-cases/abbvie-inc?utm_source=PR&utm_medium=link&utm_campaign=abbvie&mktm=r

CANNOT VIEW THIS VIDEO? PLEASE CLICK HERE

TO VIEW OUR COMPLAINT, PLEASE CLICK HERE

LEAD PLAINTIFF DEADLINE: JUNE 6, 2022

CLASS PERIOD: APRIL 30, 2021 through AUGUST 31, 2021

CONTACT AN ATTORNEY TO DISCUSS YOUR RIGHTS: James Maro, Esq. (484) 270-1453 or Email at info@ktmc.com

Kessler Topaz is one of the world's foremost advocates in protecting the public against corporate fraud and other wrongdoing. Our securities fraud litigators are regularly recognized as leaders in the field individually and our firm is both feared and respected among the defense bar and the insurance bar. We are proud to have recovered billions of dollars for our clients and the classes of shareholders we represent.

ABBVIE'S ALLEGED MISCONDUCT

AbbVie is one of the world's largest pharmaceutical companies. The company's revenues will come under significant pressure in the coming years when its best-selling drug, Humira, will lose patent protection in 2023. Accordingly, AbbVie's future revenue and earnings depend in large part on its ability to develop new sources of revenue to offset Humira's lost sales. Rinvoq-an anti-inflammatory drug manufactured by AbbVie and used to treat rheumatoid arthritis (RA) and other diseases by inhibiting Janus kinase (JAK) enzymes-was touted as one such drug. Rinvoq was initially approved in the United States to treat only moderate to severe RA. However, AbbVie was actively pursuing additional treatment indications and, in 2020, asked the U.S. Food and Drug Administration (FDA) to approve Rinvoq for the treatment of several other diseases.

As is relevant here, Rinvoq is similar to other JAK inhibitor drugs, including Xeljanz, manufactured by Pfizer Inc. When the FDA approved Xeljanz in 2012 for the treatment of RA, it required an additional safety trial to evaluate Xeljanz's risk of triggering certain serious side effects. Beginning in February 2019, the FDA repeatedly warned the public that the safety trial indicated that Xeljanz's use could lead to serious heart-related issue, cancer, and other adverse events. Notwithstanding the similarities between Rinvoq and Xeljanz, during the Class Period, Defendants assured investors that Rinvoq was far safer than Xeljanz and not subject to the same regulatory risks.

However, investors began to learn the truth about Rinvoq's significant risks on June 25, 2021, when AbbVie revealed that the FDA was delaying its review of expanded treatment applications for Rinvoq due to the safety concerns associated with Xeljanz. On this news, the price of AbbVie common stock declined $1.76 per share, or approximately 1.5%, from a close of $114.74 per share on June 24, 2021, to close at $112.98 per share on June 25, 2021.

Then, on September 1, 2021, the FDA announced that final results from the Xeljanz safety trial established an increased risk of serious adverse events, even with low doses of Xeljanz. As a result, the FDA determined that it would require new and updated warnings for Xeljanz and Rinvoq because Rinvoq "share[s] similar mechanisms of action with Xeljanz" and "may have similar risks as seen in the Xeljanz safety trial." The FDA also indicated that it would further limit approved indications for Rinvoq as a result of these safety concerns. On this news, the price of AbbVie common stock declined $8.51 per share, or more than 7%, from a close of $120.78 per share on August 31, 2021, to close at $112.27 per share on September 1, 2021.

After the Class Period, on December 3, 2021, AbbVie announced that the FDA had updated Rinvoq's label to require additional safety warnings and limit marketing of Rinvoq to only its use after treatment with other drugs has failed. On January 11, 2022, Defendants admitted that these changes to Rinvoq's label would negatively impact sales, forcing the Company to reduce its long-term guidance for Rinvoq's sales in 2025.

The complaint alleges that, throughout the Class Period, the Defendants made materially false and/or misleading statements, about the company's business and operations. Specifically, Defendants misrepresented and/or failed to disclose that: (1) safety concerns about Xeljanz extended to Rinvoq and other JAK inhibitors; (2) as a result, it was likely that the FDA would require additional safety warnings for Rinvoq and would delay the approval of additional treatment indications for Rinvoq; and (3) therefore, Defendants' statements about the company's business, operations, and prospects lacked a reasonable basis, As a result of the Defendants' wrongful acts and omissions, and the significant decline in the market value of AbbVie's securities, AbbVie investors have suffered significant damages.

WHAT CAN I DO?

AbbVieinvestors may, no later than June 6, 2022, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLPor other counsel, or may choose to do nothing and remain an absent class member. Kessler Topaz Meltzer & Check, LLP encourages AbbVie investors who have suffered significant losses to contact the firm directly to acquire more information.

CLICK HERE TO SIGN UP FOR THE CASE

WHO CAN BE A LEAD PLAINTIFF?

A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequate and typical of the proposed class of investors. The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.

ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP

Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country and around the world. The firm has developed a global reputation for excellence and has recovered billions of dollars for victims of fraud and other corporate misconduct. All of our work is driven by a common goal: to protect investors, consumers, employees and others from fraud, abuse, misconduct and negligence by businesses and fiduciaries. For more information about Kessler Topaz Meltzer & Check, LLP please visit www.ktmc.com.

CONTACT:

Kessler Topaz Meltzer & Check, LLP
James Maro, Jr., Esq.
280 King of Prussia Road
Radnor, PA 19087
(484) 270-1453
info@ktmc.com

SOURCE: Kessler Topaz Meltzer & Check, LLP



View source version on accesswire.com:
https://www.accesswire.com/701263/Investor-Reminder-Kessler-Topaz-Meltzer-Check-LLP-Reminds-Investors-of-Deadline-in-Securities-Fraud-Class-Action-Lawsuit-Filed-Against-AbbVie-Inc

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IBM, ABBV, & TWTR Class Actions: Bronstein, Gewirtz & Grossman, LLC, A Leading Class Action Firm Reminds Investors to Actively Participate

Bronstein, Gewirtz & Grossman, LLC reminds investors that a class action lawsuit has been filed against the following publicly-traded companies. You can review a copy of the Complaints by visiting the links below or you may contact Peretz Bronstein, Esq. or his Investor Relations Analyst, Yael Nathanson of Bronstein, Gewirtz & Grossman, LLC at 212-697-6484. If you suffered a loss, you can request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. A lead plaintiff acts on behalf of all other class members in directing the litigation. The lead plaintiff can select a law firm of its choice. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff

Bronstein, Gewirtz and Grossman, LLC, Tuesday, May 17, 2022, Press release picture

International Business Machines Corporation (NYSE:IBM)

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