FDA takes Pfizer’s sNDA for psoriatic arthritis drug

United States Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Pfizer’s Xeljanz (tofacitinib citrate) 5 mg twice daily (BID) and XeljanzXR extended release 11 mg once daily use the treatment of adult patients with active psoriatic arthritis (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, Pfizer said in its press release.

The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in December 2017 for the sNDAs.