FDA Issues Complete Response Letter to sBLA for Arcalyst

Regeneron announced that the FDA has issued a Complete Response Letter for 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 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.

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.

For more information call (877) REGN-777 or visit www.regeneron.com.