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U.S. FDA seeks new warnings on drugs from Pfizer, Lilly and AbbVie

Christian Fernsby |
The U.S. drugs regulator on Wednesday asked Pfizer Inc, Eli Lilly and AbbVie Inc to include information about risks of serious conditions and death from the use of a class of treatments known as JAK inhibitors.

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

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

Incyte Corp’s Jakafi and Bristol Myers Squibb’s JAK inhibitor Inrebic will not need warnings as they are not approved to treat inflammatory conditions, the agency said.


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