Pfizer (NYSE:PFE) has received FDA approval for the supplemental New Drug Application (sNDA) for Xeljanz/Xeljanz XR (tofacitinib) as a treatment of adults with active ankylosing spondylitis (AS).
About 350,000 Americans have the condition.
The Xeljanz approval covers patients who had an insufficient response or intolerance to one or more tumor necrosis factor (TNF) blockers.
Xeljanz is a Janus kinase (JAK) inhibitor and the first to find approval for five indications in the U.S., noted Mike Gladstone, global president, inflammation and immunology, Pfizer, in a press release.
To win approval, Pfizer submitted data from a Phase 3, multicenter, randomized, double-blind, placebo-controlled study.
With this approval, physicians and patients now have an additional oral treatment option that can help address this chronic and often progressive disease,” said Steven Taylor, executive vice president, mission and strategic initiatives of the Arthritis Foundation.
Filed Under: clinical trials, Drug Discovery, Rheumatology