FDA Panel Votes Against Approving Regeneron's Gout Drug

Law360, New York (May 8, 2012, 5:33 PM EDT) -- A U.S. Food and Drug Administration advisory panel voted unanimously against recommending approval of Regeneron Pharmaceuticals Inc.'s drug Arcalyst for gout flares Tuesday, with committee members saying they'd want to see longer-term studies of the drug on larger groups of patients.

The FDA's Arthritis Advisory Committee voted 11-0 that the existing efficacy and safety data don't support approving the drug, also known as rilonacept, for use over a 16-week period in preventing painful gout flares in patients initiating uric acid-lowering therapy to treat the condition, a...
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