Posted by Michael Wonder on 04 Feb 2026
Cumberland Pharmaceuticals receives FDA fast track designation for its ifetroban Duchenne muscular dystrophy program
4 February 2026 - Cumberland Pharmaceuticals announced today that the US FDA has granted fast track designation for its novel oral therapy targeting a fatal form of heart disease in Duchenne muscular dystrophy patients.
Cumberland requested fast track designation to streamline the regulatory pathway for ifetroban for Duchenne muscular dystrophy heart disease. This fast track designation follows the drug's receipt of both orphan drug designation and rare paediatric disease designation, confirming both the urgency and the significant impact of the product for this indication.
