Regeneron announced that the FDA has accepted for review its 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 sBLA submission for Arcalyst is based on positive efficacy data from PRE-SURGE 1, a North American Phase 3 trial, and PRE-SURGE 2, a similarly designed global Phase 3 trial. Both trials met the primary endpoint of reduction in the mean number of gout flares per patient during the 16-week treatment period in patients initiating uric acid-lowering therapy.

Arcalyst is currently indicated 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 years and older.

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