BridgeBio rises on FDA priority review for dwarfism drug
BBIO•The FDA granted priority review to BridgeBio Pharma’s application for infigratinib for children with achondroplasia, setting a Feb. 4, 2027, target date for a decision. In a late-stage study, treated children grew an adjusted 1.74 cm per year faster than those given placebo.
1. FDA review timeline
BridgeBio said the FDA granted priority review to its application seeking approval of experimental oral drug infigratinib for children with achondroplasia, the most common form of dwarfism. The agency set Feb. 4, 2027, as its target date for a decision.
2. Study results
The application is backed by a late-stage study that met its main and key secondary goals. Children treated with infigratinib grew an adjusted 1.74 cm per year faster than those given placebo; the drug also improved arm span and body proportions among children younger than eight. No serious side effects linked to the drug or treatment-related discontinuations were reported. BridgeBio plans to seek European approval in Q4 2026.
