On August 3, Pfizer Inc. (NYSE:$PFE) disclosed that the United States FDA’s Arthritis Advisory Committee (AAC) voted 10 to 1 to recommend approval of the proposed dose of tofacitinib. This will be used to treat adult patients suffering from active psoriatic arthritis (PsA).
Pfizer – which is based in New York City – submitted supplemental new drug applications for XELJANZ 5 mg twice daily (BID) and XELJANZ XR extended release 11 mg once daily (QD) for the pending indication.
So, what role will the Arthritis Advisory Committee play? Well, the committee will provide recommendations to the Food and Drug Administration, and then the FDA will decide whether to approve tofacitinib by December of this year.
“Today marks an important positive step in our journey to potentially bring tofacitinib to adult patients living with active psoriatic arthritis and we are pleased with the Committee’s positive recommendation,” said Michael Corbo of Pfizer. “If approved, tofacitinib would be the first Janus kinase (JAK) inhibitor for psoriatic arthritis. We look forward to working with the FDA to complete review of the applications.”
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