Pfizer Announces U.S. FDA Filing Acceptance of Supplemental New Drug Application for XELJANZ® (tofacitinib citrate) for the Treatment of Adult Patients with Active Psoriatic Arthritis

Thursday, May 04, 2017 | Personnel/Company News , Psoriasis , Pfizer


(via BusinessWire) Pfizer Inc. announced today that the United States Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) for the treatment of adult patients with active psoriatic arthritis (PsA). A separate sNDA was also accepted for XELJANZ XR® (tofacitinib citrate) extended release 11 mg once daily use in PsA. The sNDA submission is based on data from the Phase 3 Oral Psoriatic Arthritis TriaLs (OPAL) clinical development program, which consisted of two pivotal trials and a long-term extension study, evaluating the safety and efficacy of XELJANZ in patients with active PsA who had failed prior PsA treatments. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in December 2017 for the sNDAs.

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