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news.Regeneron has received US FDA approval for review of supplemental Biologics License Application (sBLA) for Arcalyst Injection for subcutaneous use to prevent gout flares in patients initiating uric acid-lowering therapy.
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Arcalyst is used to treat Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).
The sBLA submission for Arcalyst is backed by positive efficacy data from PRE-SURGE 1 and PRE-SURGE 2 Phase 3 trials.
Both the 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.