Repligen Corp (RGEN)

[surf1944]

12:27AM Repligen receives Complete Response Letter From FDA for ARCALYST sBLA for the prevention of gout flares in patients initiating uric acid-lowering therapies (RGEN) 4.05 : Co announces the FDA 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 CRL 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. 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.