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Cumberland plans NDA submission for ifetroban to treat cardiomyopathy associated with Duchenne muscular dystrophy
CPIXCumberland Pharmaceuticals Inc
Cumberland Pharmaceuticals announced it will submit a New Drug Application (NDA) to the FDA for ifetroban as a treatment for cardiomyopathy associated with Duchenne muscular dystrophy (DMD). The decision follows a pre-NDA meeting with the FDA in October 2026. The submission will rely on data from the Phase 2 FIGHT DMD trial, which showed a statistically significant 5.4% absolute improvement in left ventricular ejection fraction compared to controls, along with open-label extension data and natural history databases. The FDA granted rolling review status for the application but expressed concerns regarding the sufficiency of the data package for approval. Cumberland Pharmaceuticals is an innovation-focused biopharmaceutical company developing new therapies to address significant unmet medical needs.