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The FDA Arthritis Advisory Committee voted 10-1 today for recommending approval of the supplemental new drug application for tofacitinib in the treatment of adult patients with active psoriatic arthritis.The meeting focused on two phase 3 placebo-controlled trials that investigated the efficacy and safety of tofacitinib 5 mg twice daily and 10 mg twice daily (Xeljanz, Pfizer Inc.), as well as one ongoing phase 3 open-label, long-term extension study. Results showed tofacitinib reduced signs and symptoms of psoriatic arthritis (PsA) and improved physical function, and had a safety profile consistent with the established safety profile in rheumatoid arthritis (RA), with no new safety signals identified. Tofacitinib has previously been approved for treatment of adult patients with moderately to severely active RA and who have had an inadequate response or intolerance to methotrexate.
Original Article: FDA advisory committee recommends approval of tofacitinib for PsANEXT ARTICLE
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