PhaseBio Awarded FDA Orphan Drug Designation for Cardiomyopathy Treatment

The FDA has granted PhaseBio Pharmaceuticals orphan drug designation for its Vasomera injection for the treatment of cardiomyopathy associated with dystrophinopathies, including Duchenne muscular dystrophy, Becker muscular dystrophy and X-linked dilated cardiomyopathy.

PhaseBio is planning a Phase 2a study of the candidate to begin in the first quarter of 2016. Current treatments have focused on preventing skeletal muscle loss and preserving respiratory function.

The therapy also has received orphan drug designation for the treatment of World Health Organization Group I pulmonary arterial hypertension.