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Regeneron Pharmaceuticals, Inc. Receives Complete Response Letter From FDA For ARCALYST (rilonacept) sBLA For The Prevention Of Gout Flares In Patients Initiating Uric Acid-Lowering Therapies


Monday, 30 Jul 2012 07:25pm EDT 

Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter for the supplemental biologics license application (sBLA) for ARCALYST (rilonacept) Injection for Subcutaneous Use for the prevention of gout flares in patients initiating uric acid-lowering therapy. The Complete Response Letter states that the FDA cannot approve the application in its current form. The agency has requested additional clinical data, as well as additional Chemistry, Manufacturing, and Controls (CMC) information related to a proposed new dosage form. The FDA's action does not impact the approved indication of ARCALYST 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. 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. 

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