FDA Grants Priority Review for Oral Achondroplasia Treatment in Children

The FDA has accepted BridgeBio Pharma's New Drug Application for oral infigratinib, granting it Priority Review for achondroplasia in children. This investigational drug, which has multiple special designations, could become the first oral therapy for the condition if approved by the PDUFA target date of February 4, 2027. This development offers a potential new treatment option for a rare pediatric disease.