Biotech

  • With this approval, HUMIRA, an anti-TNF monoclonal antibody, offers pediatric patients from five years of age with moderately to severely active ulcerative colitis (UC) the first subcutaneous anti-TNF treatment option 1
  • Approval based on results from the pivotal Phase 3 ENVISION I study, the largest clinical trial in pediatric ulcerative colitis to date, showing HUMIRA provided significant rates of response and remission both at week 8 and 52 1,2

ABBVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that Health Canada has approved HUMIRA ® (adalimumab) for inducing and maintaining clinical remission in pediatric patients five years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy including corticosteroids andor azathioprine or 6-mercaptopurine or who are intolerant to such therapies. 1 With this approval, HUMIRA offers pediatric patients with moderately to severely active ulcerative colitis the first subcutaneous anti-TNF therapeutic option. 1

"Ulcerative colitis is a miserable illness when it is not well controlled, and it has a significant impact on the lives of children and adolescents. When the disease is active, it is disabling and embarrassing, and affects how children can engage in their normal lives with peers and at school. Although we are able to treat a lot of children who have ulcerative colitis today, there is still a group of children and adolescents that we cannot help as well as we would like, which is why we do need access to new therapies," said Dr. Anne Griffiths , Co-Lead, Inflammatory Bowel Disease Centre at the Hospital for Sick Children.

Ulcerative colitis is characterized by inflammation of the large intestine with symptoms ranging from mild to severe bowel urgency and bowel incontinence as well as weight loss and fatigue. 4,5 It remains a lifelong condition that is not adequately controlled in many patients, underscoring the need for more treatment options. 3,4 Children with ulcerative colitis may fail to develop or grow properly due to malabsorption of nutrients by the diseased bowel. 5 Significant unmet needs remain in moderate to severe pediatric ulcerative colitis, compared to adults, as pediatric patients tend to have more extensive disease often causing significant illness in children. 4,6

Cal Spellman , who is now 17, remembers getting diagnosed when he was 11 years old. "It was very scary for me. As a kid, it can be intimidating when a doctor says you have a chronic illness, and even though it is treatable, it can be hard to manage. I remember having a really difficult time when I was about 12. I was hospitalized twice, four months apart from each other. I was having uncontrollable symptoms, which is particularly hard for someone going through puberty, when you are feeling self-conscious about things. But for anyone who is newly diagnosed, know that it does get better. It will be hard, but it is something you can manage, and it is possible to live a normal life," he explained.

" Canada has one of the highest rates of inflammatory bowel disease (IBD) in the world 5 . With the number of cases increasing in children, it is important that we continue to expand the number of pediatric treatment options available" said Susan Cowan , CEO of Crohn's and Colitis Canada. "Ulcerative colitis, one of the main forms of IBD, is an unpredictable disease often requiring medication to manage debilitating symptoms. The introduction of a new therapy for children living with ulcerative colitis is an important advancement."

"This approval marks an important milestone for children and adolescents living with ulcerative colitis, who often struggle to control this lifelong condition, particularly because pediatric patients tend to have more extensive disease," added Tracey Ramsay , Vice President and General Manager, AbbVie Canada. "AbbVie is proud of our heritage and dedication to discovering and delivering innovative therapies that help adults and children living with inflammatory bowel disease."

About the ENVISION I Phase 3 Study 2,7

The Health Canada approval is based on results from the ENVISION I study, a Phase 3, randomized, double-blind, multicenter study designed to evaluate the efficacy, safety and the pharmacokinetics of HUMIRA in pediatric patients (ages 4-17) with moderate to severe ulcerative colitis, administered subcutaneously.

The ENVISION I study showed that HUMIRA met the co-primary endpoints of clinical remission at week 8 and, among those who responded at week 8, clinical remission at one year (52 weeks). 1,2

No new safety signals for HUMIRA were observed in this study. 1,2 In patients exposed to HUMIRA during the study, 23 percent experienced a serious adverse event. 1,2 The most frequently reported (greater than or equal to five percent) treatment-emergent adverse events during induction and maintenance periods were headache and ulcerative colitis. 1,2 No deaths, malignancies, active tuberculosis or demyelinating disease were observed in this study. 1,2

More information on this trial can be found at www.clinicaltrials.gov (NCT02065557).

About HUMIRA

HUMIRA resembles antibodies normally found in the body. It works by blocking TNF-α, a protein that, when produced in excess, plays a central role in the inflammatory responses of many immune-mediated diseases.

For further information, please see the HUMIRA Product Monograph available on www.abbvie.ca .

About AbbVie in Gastroenterology

AbbVie has focused on improving care in gastroenterology for more than 10 years. With a robust clinical trial program in inflammatory bowel disease (IBD), we are committed to cutting-edge research to drive exciting discoveries and developments in Crohn's disease and ulcerative colitis. By innovating, learning, and adapting, AbbVie aspires to eliminate the burden of IBD and make a long-term impact on the lives of people with IBD.

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.ca and www.abbvie.com . Follow @abbviecanada on Twitter or find us on Facebook , LinkedIn and Instagram .

References:

  1. HUMIRA (adalimumab) Product Monograph. AbbVie Corporation. Available at: https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/HUMIRA_PM_EN.pdf . Accessed on April 21, 2021 .
  2. Croft N.M., et al.  Efficacy and safety of adalimumab in pediatric patients with moderate to severe ulcerative colitis: results of a randomized-controlled phase 3 study. UEGJ . 2020;8(8S):98-99.
  3. The Economic Costs of Crohn's Disease and Ulcerative Colitis. Access Economics Pty Limited. 2007. Available at: https://www.crohnsandcolitis.com.au/site/wp-content/uploads/Deloitte-Access-Economics-Report.pdf .
  4. Romano, C., et al., Management of Acute Severe Colitis in Children With Ulcerative Colitis in the Biologics Era. Pediatrics. 2016;137(5):e20151184.
  5. Crohn's and Colitis Canada. 2018 Impact of Inflammatory Bowel Disease Report. Available at : https://crohnsandcolitis.ca/Crohns_and_Colitis/documents/reports/2018-Impact-Report-LR.pdf . Accessed March 29, 2020 .
  6. Jakobsen C., et al. Differences in phenotype and disease course in adult and paediatric inflammatory bowel disease—a population-based study. Aliment Pharmacol Ther. 2011;34(10):1217–1224pmid:21981762.
  7. Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/record/NCT02065557 . Accessed on October 6, 2020 .

SOURCE AbbVie Canada

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ABBV DEADLINE: Kessler Topaz Meltzer & Check, LLP Reminds Investors of AbbVie, Inc. of Deadline in Securities Fraud Class Action Lawsuit and Encourages Investors with Substantial Losses to Contact the Firm

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").

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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

TO VIEW OUR 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?
AbbVie investors may, no later than June 6, 2022 , seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLP or 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

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SOURCE Kessler Topaz Meltzer & Check, LLP

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Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Aurinia, Stronghold, Lilium, and Li-Cycle and Encourages Investors to Contact the Firm

Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf of stockholders of Aurinia Pharmaceuticals, Inc. (NASDAQ: AUPH), Stronghold Digital Mining, Inc. (NASDAQ: SDIG), Lilium N.V. (NASDAQ: LILM), and Li-Cycle Holdings Corp. (NYSE: LICY). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link provided.

Aurinia Pharmaceuticals, Inc. (NASDAQ: AUPH)

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Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Aurinia, Stronghold, Lilium, and Li-Cycle and Encourages Investors to Contact the Firm

Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf of stockholders of Aurinia Pharmaceuticals, Inc. (NASDAQ: AUPH), Stronghold Digital Mining, Inc. (NASDAQ: SDIG), Lilium N.V. (NASDAQ: LILM), and Li-Cycle Holdings Corp. (NYSE: LICY). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link provided.

Aurinia Pharmaceuticals, Inc. (NASDAQ: AUPH)

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INVESTOR DEADLINE: Aurinia Pharmaceuticals Inc. Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit - AUPH

The law firm of Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) securities between May 7, 2021 and February 25, 2022, both dates inclusive (the "Class Period") have until June 14, 2022 to seek appointment as lead plaintiff in Ortmann v. Aurinia Pharmaceuticals Inc. , No. 22-cv-02185. Commenced in the Eastern District of New York on April 15, 2022, the Aurinia class action lawsuit charges Aurinia and certain of its top executive officers with violations of the Securities Exchange Act of 1934.

If you suffered significant losses and wish to serve as lead plaintiff of the Aurinia class action lawsuit, please provide your information here:

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ROSEN, RESPECTED INVESTOR COUNSEL, Encourages Aurinia Pharmaceuticals Inc. Investors With Losses Over $100K to Secure Counsel Before Important Deadline in Securities Class Action - AUPH

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) between May 7, 2021 and February 25, 2022, inclusive (the "Class Period"), of the important June 14, 2022 lead plaintiff deadline.

SO WHAT: If you purchased Aurinia securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

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ROSEN, RESPECTED INVESTOR COUNSEL, Encourages AbbVie Inc. Investors With Losses Over $100K to Secure Counsel Before Important Deadline in Securities Class Action - ABBV

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of ABBVie Inc. (NYSE: ABBV) between April 30, 2021 and August 31, 2021, inclusive (the "Class Period"), of the important June 6, 2022 lead plaintiff deadline.

SO WHAT: If you purchased AbbVie securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

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