FDA Accepts BridgeBio’s NDA for BBP‑418 as Potential First Limb‑Girdle Muscular Dystrophy Treatment

The U.S. Food and Drug Administration (FDA) has accepted BridgeBio Pharma’s New Drug Application (NDA) for BBP-418, an oral investigational therapy for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). The agency granted Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026.

If approved, BBP-418 would be the first and only therapy specifically for LGMD2I/R9 and could mark the first FDA‑approved treatment for any form of limb‑girdle muscular dystrophy, addressing a significant unmet need in this rare neuromuscular disease. The FDA does not currently plan to convene an advisory committee meeting for this application.

BBP-418 is an oral glycosylation substrate therapy (a ribitol formulation) that showed strong efficacy and safety in the Phase 3 FORTIFY trial, positioning BridgeBio to potentially launch the drug in late 2026 or early 2027 if regulatory approval is obtained.