Posted by Michael Wonder on 03 May 2017
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
3 May 2017 - Pfizer announced today that the US FDA has accepted for review the supplemental new drug application for Xeljanz (tofacitinib citrate) 5 mg twice daily for the treatment of adult patients with active psoriatic arthritis.
A separate application was also accepted for Xeljanz XR (tofacitinib citrate) extended release 11 mg once daily use in psoriatic arthritis.
The 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 psoriatic arthritis treatments.
The FDA has provided an anticipated Prescription Drug User Fee Act action date in December 2017 for the applications.
