Cumberland Pharmaceuticals Plans Ifetroban NDA for DMD Cardiomyopathy
Cumberland Pharmaceuticals (CPIX) plans to seek FDA approval for ifetroban to treat DMD-related cardiomyopathy, using Phase 2 trial data and natural-history databases. The FDA granted a rolling review but raised concerns about evidence sufficiency. The Phase 2 trial showed a 5.4% improvement in left ventricular ejection fraction (p=0.002).
