BridgeBio Submits NDA to FDA for BBP-418 for Individuals Living with LGMD2I/R9
BridgeBio Pharma has submitted a New Drug Application (NDA) to the FDA for BBP-418, a potential first and only treatment for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). The submission includes positive interim Phase 3 FORTIFY trial data demonstrating significant improvements in ambulation and pulmonary function, and a favorable safety pr…