Regeneron Pharmaceuticals Inc. (REGN) announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration or FDA voted against approval of Arcalyst (rilonacept) Injection for Subcutaneous Use for the proposed indication for the prevention of gout flares in patients initiating uric acid-lowering therapy.
The Committee's recommendation will be considered by the FDA in its review of the supplemental Biologics License Application (sBLA) for Arcalyst, but the Committee's recommendation is not binding on the FDA.
Regeneron submitted an sBLA for marketing approval of Arcalyst in the United States and has been granted a target date for an FDA decision of July 30, 2012.
Arcalyst is currently indicated in the U.S. for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older.
Rilonacept is also approved, but not marketed, in the E.U. for the same patient population. Arcalyst is not approved, but is currently under review by the U.S. FDA, for the prevention of gout flares in patients initiating uric acid-lowering therapy.
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