BridgeBio says FDA accepts infigratinib NDA for achondroplasia, grants priority review
BBIO•The FDA accepted BridgeBio’s new drug application for oral infigratinib for children with achondroplasia and granted priority review, setting a Feb. 4, 2027, target action date. The Phase 3 PROPEL 3 study showed a +2.10 cm/year annualized height-velocity treatment effect.
1. Priority review granted
The FDA accepted BridgeBio’s NDA for oral infigratinib in children with achondroplasia and granted priority review. The PDUFA target action date is Feb. 4, 2027. The filing was supported by the Phase 3 PROPEL 3 study, which showed a +2.10 cm/year annualized height-velocity treatment effect.
