The US FDA is seeking new warnings about drugs from Pfizer, Lilly and AbbVie

September 1 (Reuters) – US drug regulator has asked Pfizer (PFE.N), Eli Lilly & Co (LLY.N) and AbbVie (ABBV.N) to include information on the risks of serious illness and died from the use of his medications belonging to a class of treatments known as JAK inhibitors.

This Wednesday’s warnings come from the U.S. Food and Drug Administration’s review of Pfizer Xeljanz’s arthritis drug after the first results of a February trial that showed a higher risk of serious problems. related to heart and cancer with the drug.

Shares of AbbVie closed up 7%, while Pfizer and Eli Lilly were slightly lower.

Pfizer said the update would provide significant clarity to healthcare providers about the risk / benefit profile of Xeljanz.

JAK inhibitors such as Xeljanz block inflammation-causing enzymes, known as Janus kinases, and target autoimmune diseases such as rheumatoid arthritis and ulcerative colitis.

The FDA said Lilly’s Olumiant drug and AbbVie’s Rinvoq have similar operating mechanisms, leading to the possibility of risks seen in the Xeljanz safety trial.

“Based on the available data from approved indications and research, we remain confident in Olumiant’s positive benefit-risk profile,” Lilly said.

AbbVie did not immediately respond to a request for comment.

The FDA is currently reviewing the applications of AbbVie for expanded use of its Rinvoq rheumatoid arthritis drug in patients with active psoriatic arthritis, atopic dermatitis, and ankylosing spondylitis.

“We look forward to seeing how the FDA handles the ongoing regulatory review of Rinvoq and other JAKs in atopic dermatitis and other indications, but we believe investors are now setting prices at worst for Rinvoq,” the analyst said. of Mizuho, ​​Vamil Divan, in reference to decreased shares of AbbVie.

Inhibic, Inkte Corp.’s JAK inhibitor (INCY.O), Jakafi and Bristol Myers Squibb (BMY.N), will not need warnings, as they are not approved to treat inflammatory conditions, the agency said.

Reports of Manas Mishra and Manojna Maddipatla in Bengaluru; Edited by Aditya Soni

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