"Not approvable" letter for Acthar sNDA

The USA's Questcor Pharmaceuticals' Acthar gel (repository corticotropin injection) has been rejected by the Food and Drug Administration for the treatment of infantile spasm. The letter from the agency indicates that Questcor's supplemental New Drug Application is not approvable in its current form and the company will schedule a meeting to discuss its decision on the agent, which is already approved for a range of rare disorders, including West's syndrome.

Until the company is able to meet with the FDA, it says it cannot comment on the specifics of the letter, but chief executive James Fares noted that Questcor is committed to resolve the FDA's questions as quickly as possible. "We are also in the process of evaluating our ongoing development and commercial strategies in light of this development," he added. The sNDA provided clinical data to support the addition of the infantile spasms indication to the current Acthar label, including the results from randomized clinical trials involving more than 250 patients, which were published in peer-reviewed medical literature.