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Ahead Of Sarepta Advisory Committee, FDA Feels Congressional Pressure About Public Participation

 
• By Derrick Gingery

Senators write US FDA commissioner seeking ‘fulsome public input’ at panel review of DMD gene therapy. The open public hearing is scheduled to run an average amount for a neurodegenerative advisory committee – but less than half the time of the OPH at the last Sarepta meeting.

microphone and computer
• Source: Shutterstock

In addition to carrying the weight of future development in Duchenne muscular dystrophy and potentially airing internal FDA review dynamics, the upcoming advisory committee for Sarepta Therapeutics, Inc.’s DMD gene therapy could also serve as an exhibit on the potential impact of public comments.

Sarepta’s SRP-9001 (delandistrogene moxeparvovec) will go before the US FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee on 12 May,...

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