BridgeBio announces FDA acceptance and priority review of NDA for oral infigratinib for children with achondroplasia
BBIO•The FDA accepted BridgeBio’s NDA for oral infigratinib for children with achondroplasia and granted priority review, setting a target action date of February 4, 2027. BridgeBio anticipates a U.S. launch upon approval and plans to submit an MAA to the EMA in the fourth quarter of 2026.
1. FDA review timeline
The FDA accepted BridgeBio Pharma’s NDA for oral infigratinib for children with achondroplasia and granted priority review. The agency set a PDUFA target action date of February 4, 2027.
2. Company plans
BridgeBio anticipates a U.S. launch upon approval and plans to submit an MAA for achondroplasia to the EMA in the fourth quarter of 2026.
