FDA seeks new warnings on arthritis drugs

pharmafile | September 2, 2021 | News story | Medical Communications  

The FDA has requested that Pfizer, Eli Lilly, and AbbVie include additional warnings on their arthritis drugs about the risks of serious conditions and death that can occur.

The request follows the FDA’s review of Pfizer’s drug Xeljanz after a February trial found an increased risk of serious heart-related problems and cancer with the treatment.

Pfizer said the update would bring important clarity for healthcare providers on the risk/benefit profile of Xeljanz.

JAK inhibitors like 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 drug Olumiant and AbbVie’s Rinvoq have similar operating mechanisms, leading to the possibility of risks seen in the Xeljanz safety trial.

Lilly said: “Based on available data across approved and investigational indications, we remain confident in the positive benefit-risk profile of Olumiant”.

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

Kat Jenkins

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