Cumberland receives fast track designation for DMD oral therapy from FDA

Cumberland (CPIX) Pharmaceuticals announced that the FDA has granted Fast Track Designation for its novel oral therapy targeting a fatal form of heart disease in Duchenne muscular dystrophy, or DMD, patients. Under Fast Track, Cumberland can also submit portions of an application for marketing approval on a rolling basis. Cumberland requested Fast Track Designation to streamline the regulatory pathway for ifetroban for DMD heart disease. This Fast Track Designation follows the drug’s receipt of both Orphan Drug Designation and Rare Pediatric Disease Designation, confirming both the urgency and the significant impact of the product for this indication.