Switzerland approves Pfizer's Xeljanz for RA

Pfizer Inc. (NYSE:PFE) said Swissmedic approved twice-daily 5 and 10 mg doses of Xeljanz tofacitinib as monotherapy or in combination with a DMARD to treat adults with moderate to severe active rheumatoid arthritis who have an inadequate response or intolerance to methotrexate. The pharma said it expects a final decision from the Swiss pricing authority on Xeljanz's price "soon" and plans to launch the oral pan-Janus kinase (JAK) inhibitor in Switzerland in the next few months.

In April, EMA's CHMP recommended against approval of an MAA for Xeljanz to treat moderate to severe RA because the committee "did not believe that a consistent reduction in disease activity and structural damage had been sufficiently demonstrated." Pfizer is seeking a re-examination of the opinion (see BioCentury Extra, April 25). ...