Posted by Michael Wonder on 15 Dec 2021
U.S. FDA approves Pfizer’s Xeljanz (tofacitinib) for the treatment of active ankylosing spondylitis
14 December 2021 - Pfizer announced today that the U.S. FDA has approved the supplemental new drug application for Xeljanz/Xeljanz XR (tofacitinib) for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more tumour necrosis factor blockers.
The approval of Xeljanz for ankylosing spondylitis is based on data from a Phase 3, multicenter, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of tofacitinib 5 mg twice daily versus placebo in 269 adult patients living with active ankylosing spondylitis.
