Pfizer gets FDA thumbs up for first once-daily RA drug Xeljanz XR

The Food and Drug Administration has approved US pharma giant Pfizer’s (NYSE: PFE) Xeljanz XR (tofacitinib citrate) extended-release tablets for the once-daily treatment of moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate (MTX).

Xeljanz XR is the first and only once-daily oral RA treatment in its class, known as Janus kinase (JAK) inhibitors, the company noted. Standard Xeljanz is approved in more than 45 countries around the world for the treatment of moderate to severe RA as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs (DMARDs).

The availability of Xeljanz XR provides physicians with a new treatment option for people with RA who may prefer an oral once-daily treatment,” said Roy Fleischmann, clinical professor in the Department of Internal Medicine at the University of Texas Southwestern Medical Center and co-medical director, Metroplex Clinical Research Center.