HP Acthar Gel is a natural adrenocorticotropic hormone (ACTH) designed to provide a prolonged release after intramuscular or subcutaneous injection.
Acthar is currently approved in the US for the treatment of acute exacerbations of multiple sclerosis, nephrotic syndrome, infantile spasms (IS) and 15 other diseases and disorders.
In conjunction with approval of the IS indication, and as a result of the FDA’s orphan designation for Acthar in the treatment of IS, the FDA has also granted Acthar a seven-year exclusivity period during which the FDA is prohibited from approving any other adrenocorticotropic hormone (ACTH) formulation for IS unless the other formulation is demonstrated to be clinically superior to Acthar.
Also, along with the approval notice the FDA has approved a new Acthar label and has finalized a medication guide for Acthar in the treatment of IS.
Questcor will provide this guide with each Acthar prescription for IS and assess the guide’s usefulness and usage by caregivers of IS patients.
Questcor president and CEO Don Bailey said that the FDA approval of Acthar for IS treatment provides an opportunity to begin raising awareness among healthcare providers and parents about the importance of early diagnosis and appropriate treatment of IS. It will also help to ensure rapid access to Acthar for infants suffering from this devastating condition.
Questcor executive vice president and chief business officer Steve Cartt said that the Acthar nephrotic syndrome indication, which remains unchanged, will enable us to continue our commercialization plans to address this serious, difficult-to-treat kidney disorder. New data related to the use of Acthar in the treatment of nephrotic syndrome are expected to be presented at the American Society of Nephrology Annual Meeting in November 2010.