ARTICLE | Regulation
FDA grants priority review to Stealth’s therapy, removing uncertainty over a priority review voucher needed for economic viability in the ultra-rare disease
By Steve Usdin, Washington Editor
May 7, 2024 9:42 PM UTC
FDA has granted priority review status to an NDA for elamipretide to treat Barth syndrome, reversing a decision to assign the drug standard review status.
The agency accepted the NDA on March 29 following a years-long struggle by Stealth BioTherapeutics Inc. and Barth syndrome patient advocates to persuade FDA to review the therapy. …
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- Source: https://www.biocentury.com/article/652355/another-step-in-what-could-be-the-path-to-the-first-barth-syndrome-therapy