SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for rheumatoid arthritis ahead of the day the agency was scheduled to decide whether or not to approve it, the agency said Tuesday.
The FDA announced the approval of Pfizer's Xeljans (tofacitinib) for adults with moderately to severely active RA who have responded inadequately or can't tolerate methotrexate, a commonly used generic drug for the disease. The FDA had been scheduled to decide whether or not to approve the drug on Nov. 21. RA affects about 1.5 million Americans, according to the Centers for Disease Control and Prevention.
"Xeljanz provides a new treatment option for adults suffering from the debilitating disease of RA who have had a poor response to methotrexate," FDA Division of Pulmonary, Allergy and Rheumatology Products director Badrul Chowdhury said.