Recently, Questcor Pharmaceuticals Inc (QCOR) announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) filed by Questcor seeking marketing approval for its drug Acthar (repository corticotrophin injection).
The application seeks FDA approval to sell the drug for treating infantile spasms (IS), a rare form of childhood epilepsy. The U.S. agency is expected to decide on whether to approve Acthar for this additional indication by June 11, 2010 (target date).
The Questcor drug has already received FDA’s green light for treating certain disorders with an inflammatory component, including the treatment of multiple sclerosis exacerbations and the treatment of nephrotic syndrome. Even though the current sNDA seeks FDA approval to market Acthar for IS, the drug is already used by many neurologists for treating infants suffering from IS following the guidelines published by the American Academy of Neurology and the Child Neurology Society.
The disease affects infants in the first year of their lives and can be potentially fatal. Acthar has been granted orphan drug designation by the FDA for this indication, which implies that Questcor will enjoy marketing exclusivity of seven years in the United States, once the drug is approved for IS.
Questcor Pharmaceuticals, founded in 1990 and headquartered in Union City, California, is a specialty pharmaceutical company which provides prescription drugs for central nervous system disorders. Apart from Acthar, Questcor markets Doral (quazepam), for treating insomnia patients.
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