New warnings and restrictions placed on Sarepta Therapeutics’ gene therapy last week by the Food and Drug Administration have cast a spotlight on an important but overlooked heart-safety risk.
“Acute, serious, and life-threatening” cases of heart inflammation called myocarditis and elevations of troponin-I, a protein released by dying heart-muscle cells, have been reported in patients treated with Elevidys, Sarepta’s gene therapy for Duchenne muscular dystrophy, according to its prescribing label updated on Friday.
A previous version of the Elevidys label noted only that “acute and serious” myocarditis and troponin-I elevations had been observed.
