2023-05-12 18:31:20 ET
- A panel of advisors to the US FDA has voted that the benefits of Sarepta Therapeutics' ( NASDAQ: SRPT ) gene therapy SRP-9001 for Duchenne muscular dystrophy outweigh the risks.
- The vote from members of the Cellular, Tissue, and Gene Therapies Advisory Committee was 8-6.
- Sarepta is partnered with Catalent ( CTLT ) on SRP-9001, which is also known as delandistrogene moxeparvovec. Roche ( OTCQX:RHHBY ) also has a partnership to market the product overseas.
- The FDA is set to make a decision on SRP-9001 by the end of May.
- In briefing documents released prior to the meeting, FDA scientists expressed concerns over SRP-9001's efficacy.
For further details see:
Sarepta muscular dystrophy drug SRP-9001 endorsed by FDA advisors