Acthar Gel Effective, Safe for Treating Infantile Spasms, FDA Advisory Panel Says

A Food and Drug Administration advisory panel voted that Acthar Gel (repository corticotropin injection) is effective and safe for the treatment of infantile spasms, an FDA spokeswoman told BNA May 18.

FDA’s Peripheral and Central Nervous System Drugs Advisory Committee May 6 voted 22 to 1 that the drug’s sponsor, Questcor Pharmaceuticals, had provided substantial evidence of the drug’s effectiveness for treating patients with infantile spasms, the spokeswoman said. The panel also voted 16 to 7 that Questcor has provided evidence to support the view that a short course of treatment (two weeks followed by a two week tapering regimen) ...