AbbVie Facing Class Action Following Stock Price Drops Linked to Xeljanz, Rinvoq Safety Concerns

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AbbVie faces a proposed class action that alleges the pharmaceutical company misled investors by “condition[ing]” them to believe Rinvoq, a rheumatoid arthritis treatment, was far safer than Xeljanz, a drug the FDA has associated with elevated risks of serious health issues. 

The 22-page lawsuit alleges AbbVie made materially false or misleading statements and failed to disclose that safety concerns surrounding Xeljanz, a drug manufactured by Pfizer, also applied to Rinvoq and other pharmacologically similar drugs, and that as a result it was likely the FDA would call for additional safety warnings for Rinvoq and delay the approval of additional treatment indications. The case stresses that Rinvoq was touted by AbbVie effectively as the sales-driving successor to Humira, another anti-inflammatory drug, whose sales the company expects to decline once biosimilar treatments are allowed to enter the market in 2023. 

The filing says that AbbVie investors were initially injured financially after the company revealed in June 2021 that the FDA would not complete a review of several of the expanded treatment indications for Rinvoq by the end of the month, as previously announced, due to its ongoing evaluation of safety concerns linked with Xeljanz. 

Upon this news, the share price of AbbVie’s common stock fell $1.76 per share, or roughly 1.5 percent, to close at $112.98 per share on June 25, 2021, the case states. 

On September 1, 2021, the FDA announced that the final results of its evaluation of Xeljanz established “an increased risk of adverse events,” even at low doses, the suit continues. Accordingly, the FDA determined that it would require new and updated warnings for Zeljanz and Rinvoq, given the pharmacological similarities between the drugs, and indicated it would additionally limit approved applications for Rinvoq due to safety concerns, according to the complaint. 

Upon this news, AbbVie’s common stock price fell again, this time by more than seven percent, to close at $112.27 per share on September 1, 2021, the lawsuit says. 

The complaint goes on to state that on December 3, AbbVie announced that the FDA had updated Rinvoq’s label in accordance with its September decision. Specifically, the new label included additional information on the risks of malignancy and thrombosis, as well as mortality and cardiovascular death, myocardial infarction and stroke risks, the suit states. The new Rinvoq label also included a warning that the treatment can essentially be marketed only as an alternative option after other anti-inflammatory drugs have failed, the filing says. 

From there, in January 2022, AbbVie and its leadership admitted the changes to the Rinvoq label would harm sales, which in turn forced the company to reduce its long-term guidance for sales of the drug in 2025, according to the complaint. 

The suit looks to represent all persons and entities who purchased or otherwise acquired AbbVie securities between April 30 and August 31, 2021. 

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