Sarepta Therapeutics to Request Expansion of Elevidys to All Age Groups Following Study Results

By Denny Jacob

Sarepta Therapeutics said it will request expanding its Duchenne muscular dystrophy treatment to patients in all age groups following results of a study.

The commercial-stage biopharmaceutical company said study participants treated with Elevidys showed an increase on the North Star Ambulatory Assessment, a measure of motor function, compared to placebo-treated patients at 52 weeks, although the primary endpoint wasn't met.

Sarepta said the study of Elevidys supports the conclusion that the treatment modifies the trajectory of people dealing with Duchenne. The Phase 3 clinical study of Elevidys evaluated the treatment in patients with Duchenne between the ages of four and seven.

Elevidys received accelerated FDA approval for patients ages four through five in June.

Based on the results of the study, "we intend to move swiftly to request an update to expand the labeled indication to treat all patients," said Chief Executive Doug Ingram. He added that the leadership at the Food and Drug Administration confirmed that, based on the evidence so far, they are open to such an expansion if supported by a review of the data.

Write to Denny Jacob at [e-mail]

(END) Dow Jones Newswires

October 30, 2023 17:02 ET (21:02 GMT)

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