USFDAMay 27, 2026, 04:08 PM
BridgeBio FDA Accepts BBP-418 NDA for LGMD2I/R9 with Priority Review
AI Summary
BridgeBio Pharma announced that the FDA has accepted its New Drug Application (NDA) for BBP-418, a potential first-in-class therapy for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), for Priority Review. The FDA set a PDUFA target action date of November 27, 2026, and is not currently planning an advisory committee meeting. If approved, BBP-418 would be the first and only therapy for LGMD2I/R9, addressing a significant unmet medical need for approximately 7,000 individuals in the U.S. and Europe. The drug previously met all primary and secondary endpoints in its Phase 3 FORTIFY trial.
Key Highlights
- FDA accepted New Drug Application (NDA) for BBP-418 for LGMD2I/R9 with Priority Review.
- PDUFA target action date is set for November 27, 2026.
- BBP-418 could be the first and only therapy for LGMD2I/R9 if approved.
- Addresses an unmet medical need for approximately 7,000 individuals in the U.S. and Europe.
- BBP-418 met all primary and secondary endpoints in the Phase 3 FORTIFY trial.
- FDA is not currently planning an advisory committee meeting for the application.
- BridgeBio may qualify for a Priority Review Voucher upon BBP-418 approval.
Price Impact
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