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

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

REUTERS

The U.S. drug regulator has asked Pfizer (PFE.N), Eli Lilly & Co (LLY.N) and AbbVie (ABBV.N) to include information about the risks of serious conditions and death from the use of their drugs that belong to a class of treatments known as JAK inhibitors.

The warnings on Wednesday stem from the U.S. Food and Drug Administration's review of Pfizer's arthritis drug Xeljanz after initial results from a February trial showed an increased risk of serious heart-related problems and cancer with the drug.

AbbVie shares closed down 7%, while Pfizer and Eli Lilly were slightly lower.

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.

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

AbbVie did not immediately respond to a request for comment.

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.

"We wait to see how the FDA handles the ongoing regulatory review of Rinvoq and other JAKs in atopic dermatitis and other indications, but believe investors are now pricing in a worst-case scenario for Rinvoq," Mizuho analyst Vamil Divan said, referring to the decline in AbbVie shares.

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

Reporting by Manas Mishra and Manojna Maddipatla in Bengaluru; Editing by Aditya Soni