Xeljanz tofacitinib regulatory update

Pfizer said FDA approved an sNDA for 5 and 10 mg twice-daily Xeljanz tofacitinib to include supportive patient-reported outcomes data from 3 Phase III trials in the label for the rheumatoid arthritis drug. The data showed that the doses had greater improvement from baseline compared to placebo in all 8 domains of the Medical Outcomes Study Short-Form (36-Item) Health Survey (SF-36) at 3 months. The 5 mg dose of tofacitinib is marketed in the U.S. and Japan as Xeljanz to treat moderate to severe RA in adults with an inadequate response or intolerance to methotrexate. In the U.S., Pfizer had been seeking approval of both the 5 and 10 mg doses, but an FDA advisory committee recommended approval of only the lower dose because of a risk of serious infections, malignancies and liver test abnormalities with the 10 mg dose (see BioCentury, Nov. 12, 2012). ...