Xeljanz tofacitinib regulatory update

FDA approved an sNDA for 5 mg Xeljanz tofacitinib tablets from Pfizer to include radiographic response data from the Phase III ORAL Scan and ORAL Start trials in the label for the rheumatoid arthritis drug. In ORAL Scan, 84% of patients treated with 5 mg Xeljanz plus methotrexate experienced no radiographic progression as measured by mean change from baseline in modified Total Sharp Score (mTSS) at month 6 vs. 74% of patients treated with placebo and methotrexate. In ORAL Start, 73% of patients treated with 5 mg Xeljanz experienced no radiographic progression at month 6 vs. 55% of patients treated with methotrexate. 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 5 and 10 mg doses of Xeljanz, 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). ...