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BridgeBio May See Quicker Market Entry For Muscular Dystrophy Drug

 
• By Joseph Haas

BridgeBio and US FDA agreed on a path to accelerated approval for BB-418, a Phase III oral candidate for a subset of limb-girdle MD patients. If successful, it would bring BridgeBio’s third product to market.

MUSCULAR DYSTROPHY words written on label tag with medicine,syringe,keyboard and stethoscope
BridgeBio hopes to earn accelerated approval for its drug for a subset of MD patients

On the heels of positive Phase III data for its cardiomyopathy drug, hub-and-spoke company BridgeBio Pharma, Inc. has another bit of good news with an agreement with the US Food and Drug Administration on potential accelerated approval for its oral therapy for a subset of limb-girdle muscular dystrophy. The company announced on 31 July a plan to use interim data from its Phase III trial measuring levels of the protein alpha-dystroglycan (αDG) that might show that BB-418 is working on the disease’s underlying cause and read out by late 2024 or early 2025.

Being developed by BridgeBio portfolio company ML Bio Solutions, BB-418 has shown improved and stable levels of αDG over time in an ongoing Phase II study. That trial, assessing...

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