The FDA accepted two Pfizer applications to extend the approval of Xeljanz for the treatment of adult patients with active psoriatic arthritis, in both 5 mg twice-daily and 11 mg extended-release formulations.
The sNDA submissions are based on data from two Phase III trials and a long-term extension study, evaluating the safety and efficacy of Xeljanz (tofacitinib citrate) in patients who had failed prior treatments. Both Phase III studies met their primary endpoints, showing improvement compared to placebo after three months.
According to Pfizer, Xeljanz would be the first and only Janus kinase inhibitor approved for the disease. The FDA set a PDUFA action date for December 2017.