BridgeBio Gets FDA Fast-Track Designation for Limb-Girdle Muscular Dystrophy Type 2i Treatment
BridgeBio Pharma Inc. on Wednesday said the U.S. Food and Drug Administration granted fast-track designation to BBP-418 as a potential treatment for limb-girdle muscular dystrophy type 2i.
The Palo Alto, Calif., biopharmaceutical company said there are currently no approved treatment options for the genetic condition, which causes weakness and wasting of the muscles in the arms and legs.
The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.
BridgeBio said clinical trials to verify the safety and efficacy of BBP-418 are continuing.
Sept. 15, 2021