Arcalyst rilonacept regulatory update

FDA's Arthritis Advisory Committee voted 11-0 that efficacy and safety data do not support approval of Arcalyst rilonacept from Regeneron 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 earlier this month that cited concerns of an increased risk of malignancy and lack of long-term safety data for Arcalyst. The sBLA has a July 30 PDUFA date. ...