BridgeBio Announces FDA Acceptance and Priority Review of NDA for BBP-418 for LGMD2I/R9
The FDA has accepted BridgeBio's New Drug Application for BBP-418 to treat LGMD2I/R9, granting it Priority Review with a PDUFA target date of November 27, 2026. BBP-418 is poised to be the first and only approved therapy for this specific form of limb-girdle muscular dystrophy, addressing a significant unmet need in a patient population of approximately 7,000 in the U.S. and Europe. The FDA indicated it will not hold an advisory committee meeting, reducing near-term regulatory uncertainty.
Key figures
- Drug Name
- BBP-418
- Phase Of Trial
- Phase 3
- Pdufa date
- November 27, 2026
- Addressable patients us europe
- 7000
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