Advisers to the U.S. Food and Drug Administration are meeting on Friday to review Sarepta Therapeutics Inc's first-of-its-kind gene therapy for Duchenne muscular dystrophy (DMD) ahead of an approval decision expected later this month.
May 12 - Advisers to the U.S. Food and Drug Administration are meeting on Friday to review Sarepta Therapeutics Inc's
DMD is estimated to affect one-in-3,500 male births worldwide, according to the National Organization for Rare Disorders, causing progressive muscle failure. Most people with DMD do not survive beyond their thirties. Top FDA official Peter Marks told the panel that the agency had decided to hold the advisory meeting, after initially not planning one, with the idea that an open public discussion would be important for Sarepta's approval application.
On Friday, staff reviewers in a presentation said patients likely have only one chance to receive this type of therapy for DMD, and it is critical that what they get be effective and safe.
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