Regeneron (REGN) FDA Committee Votes Against ARCALYST Approval

Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) reports that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (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.

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