Investigation of AbbVie Inc.

AbbVie Inc. (ABBV) Misled Investors Regarding the Efficacy of its Drug Rinvoq    

A shareholder filed a class action on behalf of persons and entities that purchased or otherwise acquired AbbVie Inc. (NYSE: ABBV) securities between April 30, 2021 and August 31, 2021, for violations of the Securities Exchange Act of 1934.  AbbVie is one of the world’s largest pharmaceutical companies.     

According to the complaint, during the class period, defendants touted the safety of Rinvoq for further application. Specifically, AbbVie was looking to expand Rinvoq’s application from treating severe rheumatoid arthritis to treating psoriatic arthritis, ankylosing spondylitis, and atopic dermatitis.  Rinvoq is pharmacologically similar to Xeljanz, which is manufactured by Pfizer and comes with a warning that certain doses are associated with elevated risks of serious heart-related issues, cancer, and other adverse events.  Notwithstanding, defendants led investors to believe Rinvoq was far safer than Xeljanz and downplayed the likelihood that the FDA would take regulatory action against Rinvoq as a result of Xeljanz’s problematic safety profile.

On June 25, 2021, AbbVie revealed that the FDA would not complete its review of several of the expended treatment indications for Rinvoq by the end of June, as previously announced, due to ongoing evaluation of safety concerns associated with Xeljanz. 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 because 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.

On December 3, 2021, AbbVie announced the FDA had updated Rinvoq’s label in accordance with its September 1, 2021, decision. Specifically, the label would indicate the risks of malignancy and thrombosis, and the addition of mortality and MACE. Further, AbbVie can only market Rinvoq as an alternative option after other anti-inflammatory drugs have failed. On January 11, 2022, defendants admitted these changes would negatively impact sales, forcing the Company to reduce its long-term guidance for Rinvoq’s sales in 2025.


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