FDA Delays Decision on Sarepta’s DMD Gene Therapy
May 26, 2023
Source: drugdu
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By Heather McKenzie https://www.biospace.com/
Pictured: Sarepta logo on a building/courtesy of Sarepta Therapeutics
Those in the Duchenne muscular dystrophy and gene therapy spaces hoping for a milestone decision by May 29 will have to wait approximately three more weeks as the FDA set a new action date of June 22 for Sarepta’s gene therapy for the neuromuscular disease.
The FDA told the company Wednesday “it requires modest additional time to complete the review, including final label negotiations and postmarketing commitment discussions,” according to Sarepta’s announcement.
The company went on to say that the FDA indicated it is “working toward potentially granting an accelerated approval for SRP-9001” for DMD patients aged 4-5 years.
If approved, SRP-900 would be the first FDA-authorized gene therapy for DMD.
Sarepta’s shares were down 14% in pre-market trading Wednesday.
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