FDA approves Pfizer's Xeljanz for rheumatoid arthritis

Having in the summer put back its “action date” due to a request for additional analysis of the existing data in the tofacitinib New Drug Application (The Pharma Letter August 22), the US Food and Drug Administration last evening approved pharma behemoth Pfizer’s (NYSE: PFE) Xeljanz (tofacitinib) to treat adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to, or who are intolerant of, methotrexate. Pfizer shares moved up 1.2% at $25.01 in the after-hours trading, when all eyes were more focused on US presidential election results.

According to the Centers for Disease Control and Prevention, RA affects an estimated 1.5 million Americans. Xeljanz, a pill taken twice daily, works by blocking molecules called “Janus kinases,” which are important in the joint inflammation of RA. The drug is the first new oral disease-modifying antirheumatic drug (DMARD) for RA in more than a decade.

“Xeljanz provides a new treatment option for adults suffering from the debilitating disease of RA who have had a poor response to methotrexate,” said Badrul Chowdhury, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.