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news.The FDA has accepted for review Questcor Pharmaceuticals' supplemental new drug application seeking approval for HP Acthar Gel for the treatment of infantile spasms.
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Acthar Gel (repository corticotropin injection) is a natural adrenocorticotropic hormone, or ACTH, designed to provide a prolonged release after intramuscular or subcutaneous injection. It is currently indicated for the treatment of acute exacerbations of multiple sclerosis, and for several other diseases and disorders.
Supportive information for the supplemental new drug application (sNDA) includes historical data on the use of Acthar Gel in the treatment of infantile spasms, including results from randomized clinical trials involving greater than 250 patients, which were published in peer-reviewed medical literature.
“Acthar Gel is an important drug today in the treatment of infantile spasms,” said James Fares, Questcor’s president and chief executive officer. “However, we believe this filing supports an even greater role for Acthar Gel in managing this life-threatening form of childhood epilepsy. We look forward to working closely with the FDA throughout this review process.”