Panel rebuffs Arcalyst for gout

FDA's Arthritis Advisory Committee voted 11-0 that efficacy and safety data do not support approval of Arcalyst rilonacept from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) to prevent gout flares in adults initiating uric acid-lowering therapy. The panel voted 6-5 that the efficacy data included in the sBLA were adequate and supportive but voted 8-3 that the safety data were not adequate and supportive. The vote follows briefing documents released last Friday that cited concerns of an increased risk of malignancy and lack of long-term safety data for Arcalyst (see BioCentury, Extra, May 4). ...