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What Information Does US FDA Need For Stealth’s Elamipretide After CRL?

 
• By Sue Sutter

The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.

Door open, door closed
The FDA's complete response letter shut the door to regular approval, but opened the door to accelerated approval. (Shutterstock)
Key Takeaways
  • The FDA issued Stealth a complete response letter on its Barth syndrome drug elamipretide, but said it would consider accelerated approval based on an intermediate clinical endpoint, despite previously rejecting use of the expedited pathway.

A US Food and Drug Administration complete response letter that proposed accelerated approval as a potential path forward for

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