|Company Name||AbbVie Inc.|
AbbVie’s Januns kinase (“JAK”) inhibitor drug, Rinvoq, has been approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of moderate to severe rheumatoid arthritis (“RA”). In 2020, AbbVie sought regulatory approval to expand the indications for Rinvoq.
On June 25, 2021, AbbVie disclosed that the FDA would not complete its review of several of the expanded treatment indications for Rinvoq within the previously-announced timeframe due to its ongoing evaluation of safety concerns associated with other JAK inhibitor drugs.
On this news, AbbVie’s common stock fell $1.76, or 1.5%, to close at $112.98 per share on June 25, 2021, thereby injuring investors.
Then, on September 1, 2021, the FDA announced that the safety trials for other JAK inhibitor drugs had established an increased risk of serious adverse events, even with low doses, and determined that new and updated warnings would be required for those drugs as well as for Rinvoq, as it shares “similar mechanisms of action” and “may have similar risks.” The FDA also disclosed that it would further limit approved indications for Rinvoq as a result of safety concerns.
On this news, AbbVie’s common stock fell $8.51, or 7%, to close at $112.27 per share on September 1, 2021, thereby injuring investors further.
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