Sarepta Therapeutics to Request Expansion of Elevidys to All Age Groups Following Study Results
31 October 2023 - 8:17AM
Dow Jones News
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 denny.jacob@wsj.com
(END) Dow Jones Newswires
October 30, 2023 17:02 ET (21:02 GMT)
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