BridgeBio's Infigratinib Receives Priority Review for Achondroplasia
The U.S. Food and Drug Administration (FDA) has accepted BridgeBio Pharma’s New Drug Application (NDA) for infigratinib, an oral therapy targeting achondroplasia, the most common form of short-limbed dwarfism. The FDA granted Priority Review status to the application, with a decision expected by February 4, 2027. The NDA is supported by data from the phase 3 PROPEL 3 trial, which demonstrated promising results for infigratinib’s efficacy and safety profile. If approved, infigratinib could become an important treatment option for patients with achondroplasia.
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