 U.S.
FDA seeks new warnings on arthritis drugs from Pfizer, Lilly and AbbVie
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[September 02, 2021]
(Reuters) -The U.S. drug regulator has
asked Pfizer, Eli Lilly & Co and AbbVie 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.
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 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.
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 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 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.
(Reporting by Manas Mishra and Manojna Maddipatla in Bengaluru;
Editing by Aditya Soni)
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