BridgeBio says FDA accepts infigratinib NDA for achondroplasia, grants priority review
BBIO•The FDA accepted BridgeBio’s infigratinib application for children with achondroplasia and granted priority review. The target action date is Feb. 4, 2027; BridgeBio plans a U.S. launch if the drug is cleared.
1. Priority review granted
The FDA accepted BridgeBio’s new drug application for oral infigratinib to treat children with achondroplasia and granted it priority review. The target action date is Feb. 4, 2027. If cleared, infigratinib would be the first FDA-cleared oral therapy for achondroplasia, and BridgeBio plans a U.S. launch.
