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FDAnews Drug Daily Bulletin
May 25, 2012 | Vol. 9 No. 104
Arcalyst’s sBLA Review Shows Need for Attention to Target Population
Safety and efficacy data for Regeneron’s Arcalyst do not support an indication to prevent gout flares, an FDA advisory panel voted unanimously. They cited missing safety data and dissatisfaction with the patient population studied in key trials as reasons for their decision. The Arthritis Advisory Committee expressed unease with Regeneron’s broadly proposed indication for all gout patients, saying the company’s key trial should have focused on the likely population for the biologic — those at high risk for gout flares and refractory to current available therapies. They also complained of a lack of long-term safety data.
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