STAT+: FDA halts study of Sarepta treatment for Duchenne muscular dystrophy due to safety concern
Sarepta Therapeutics said Thursday that it has temporarily stopped a clinical trial of its second-generation medicine for patients with a certain type of Duchenne muscular dystrophy due to a serious safety incident reported by a patient.
The Food and Drug Administration placed a clinical hold on the Sarepta drug, called SRP-5051, after a patient in the study experienced a “serious” decrease in blood-based magnesium, a condition known as hypomagnesemia.
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