FDA Grants Priority Review to Oral Infigratinib for Children with Achondroplasia

The U.S. Food and Drug Administration (FDA) has accepted BridgeBio's New Drug Application (NDA) for oral infigratinib, granting it Priority Review for the treatment of children with achondroplasia. This designation underscores the significant unmet need for an oral targeted therapeutic option for this rare genetic condition. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of February 4, 2027.