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PRINCIPAL APPLICANT DEADLINE: JUNE 6, 2022
COURSE PERIOD: FROM APRIL 30, 2021 to AUGUST 31, 2021
CONTACT A LAWYER TO DISCUSS YOUR RIGHTS :
James Maro, Esq. (484) 270-1453 or by email at [email protected]
ABBVIE’S ALLEGED MISCONDUCT
AbbVie is one of the largest pharmaceutical companies in the world. The company’s revenues will come under significant pressure in the coming years when its top-selling drug, Humira, loses patent protection in 2023. As a result, AbbVie’s future revenues and profits are largely dependent on its ability to develop new revenue streams to offset Humira’s lost sales. Rinvoq, an anti-inflammatory drug made by AbbVie and used to treat rheumatoid arthritis (RA) and other conditions by inhibiting Janus kinase (JAK) enzymes, has been touted as one such drug. Rinvoq was originally approved in the United States to treat moderate to severe rheumatoid arthritis only. However, AbbVie was actively pursuing additional treatment indications and in 2020 applied to the US Food and Drug Administration (FDA) to approve Rinvoq for the treatment of several other conditions.
As relevant here, Rinvoq is similar to other JAK inhibitor drugs, including Xeljanz, made by Pfizer Inc. When the FDA approved Xeljanz in 2012 for the treatment of rheumatoid arthritis, it took a safety trial additional to assess the risk of Xeljanz triggering certain serious side effects. effects. Beginning in February 2019, the FDA repeatedly warned the public that safety testing indicated that using Xeljanz could lead to serious heart problems, cancer, and other adverse events. Notwithstanding the similarities between Rinvoq and Xeljanz, during the class period the defendants assured investors that Rinvoq was significantly safer than Xeljanz and not subject to the same regulatory risks.
However, investors began to uncover 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 safety concerns associated with Xeljanz. On this news, AbbVie’s common stock price declined $1.76 per share, or approximately 1.5%, from a close of $114.74 per share on June 24, 2021 to $112.98. per share on June 25, 2021.
Then, on September 1, 2021, the FDA announced that the final results of the Xeljanz safety trial established an increased risk of serious adverse events, even with low doses of Xeljanz. As a result, the FDA has determined that it will require new and updated warnings for Xeljanz and Rinvoq because Rinvoq “shares[s] similar mechanisms of action with Xeljanz” and “may have similar risks as seen in the Xeljanz safety trial. The FDA has also indicated that it will further limit the approved indications for Rinvoq due to these safety concerns. AbbVie common stock fell $8.51 per share, or more than 7%, from a close of $120.78 per share on August 31, 2021 to $112.27 per share on September 1, 2021.
After the appeal period, on December 3, 2021, AbbVie announced that the FDA had updated the Rinvoq label to require additional safety warnings and limit the marketing of Rinvoq to use only after treatment failure with other medications. On January 11, 2022, the defendants admitted that these Rinvoq label changes would negatively impact sales, causing the company to reduce its long-term forecast for Rinvoq sales in 2025.
The Complaint alleges that, throughout the Class Period, the Defendants made materially false and/or misleading statements regarding the company’s business and operations. Specifically, defendants misrepresented and/or failed to disclose that: (1) the safety concerns regarding 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 delay approval of additional treatment indications for Rinvoq; and (3) as a result, defendants’ statements about the company’s business, operations and prospects lacked a reasonable basis. Due to the defendants’ wrongful acts and omissions and the significant decline in the market value of AbbVie’s securities, AbbVie’s investors suffered substantial damages.
WHAT CAN I DO?
AbbVie investors can no later than June 6, 2022 , seek to be named as lead class representative plaintiff through Kessler Topaz Meltzer & Check, LLP or another attorney, or may choose to do nothing and remain an absentee class member. Kessler Topaz Meltzer & Check, LLP encourages AbbVie investors who have suffered significant losses to contact the company directly for more information.
CLICK HERE TO REGISTER FOR THE CASE
WHO CAN BE A PRINCIPAL APPLICANT?
A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead applicant is usually the investor or small group of investors who have the greatest financial interest and who are also adequate and typical of the proposed category of investors. The lead plaintiff chooses an attorney to represent the lead plaintiff and the class and those attorneys, if approved by the court, are the lead or class attorneys. Your ability to participate in any collection is not affected by whether or not to serve as lead plaintiff.
ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP
Kessler Topaz Meltzer & Check, LLP is filing class actions in state and federal courts nationwide and around the world. The company has developed a worldwide reputation for excellence and has recovered billions of dollars for victims of fraud and other malpractice. All of our work is guided by a common goal: to protect investors, consumers, employees and others from fraud, abuse, corporate and fiduciary misconduct and negligence. For more information about Kessler Topaz Meltzer & Check, LLP, please visit www.ktmc.com.
Kessler Topaz Meltzer & Check, LLP
James Maro, Jr., Esq.
280 King of Prussia Road
Radnor, PA 19087