Regeneron Pharmaceuticals, Inc. (REGN) said Monday that the U.S. Food and Drug Administration issued a Complete Response Letter for the supplemental biologics license application for ARCALYST 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 information related to a proposed new dosage form.
Regeneron said it is reviewing the Complete Response Letter and that it will determine appropriate next steps.
The FDA's action does not impact the approved indication of ARCALYST for the treatment of Cryopyrin-Associated Periodic Syndromes, including Familial Cold Auto-inflammatory Syndrome and Muckle-Wells Syndrome in adults and children 12 and older.
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