(Reuters) -The U.S. Food and Drug Administration said on Tuesday that it is investigating reports of two deaths due to acute liver failure in non-ambulatory Duchenne muscular dystrophy patients after receiving Sarepta Therapeutics’ gene therapy, Elevidys.
In June, Sarepta reported a second death in a patient who had received its gene therapy, which raised concerns on the safety and future demand for the treatment.
The patients who died were a 16-year-old, weighing 70 kilograms, and a 15-year-old, weighing 50 kilograms. Both boys were non-ambulatory and their deaths occurred within 90 days after treatment, the company said in an investor call last week.
The two patients showed signs of acute liver failure and were hospitalized less than two months after treatment Elevidys, the health regulator said on Tuesday.
The company did not immediately respond to a Reuters request for comment.
Elevidys is the only gene therapy approved by the U.S. drug regulator for treating Duchenne muscular dystrophy in patients aged four and above. It is a one-time gene therapy with a known risk of liver damage.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Alan Barona)
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