US FDA calls for new arthritis drug warnings from Pfizer, Lilly and AbbVie

The U.S. drug regulator has asked Pfizer, Eli Lilly & Co and AbbVie to include information about the risks of serious illness and death from the use of their drugs which belong to a class of treatments known as ‘JAK inhibitors.

Wednesday’s warnings stem from the United States Food and Drug Administration’s review of Pfizer’s arthritis drug Xeljanz after initial results from a February trial showed increased risk of serious heart problems and cancer with the drug.

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

Pfizer said the update will provide important clarity to healthcare providers on Xeljanz’s risk / benefit profile.

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

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

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

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.

Teleprinter	Security	Last	Switch	Switch %
ABBV	ABBVIE, INC.	112.27	-8.51	-7.05%
PFE	PFIZER INC.	46.04	-0.03	-0.07%
THERE IS	ELI LILLY & CO.	257.40	-0.89	-0.34%

“We are waiting to see 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 considering the worst-case scenario for Rinvoq,” said Mizuho analyst Vamil Divan, referring to the drop in AbbVie shares.

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

(Reporting by Manas Mishra and Manojna Maddipatla in Bengaluru; editing by Aditya Soni)