Oral Infigratinib Demonstrates Significant Benefits Beyond Growth in Children with Achondroplasia

New data from the Phase 3 PROPEL 3 trial of oral infigratinib in children with achondroplasia show favorable trends against placebo in clinically meaningful exploratory endpoints, including a stabilization of sleep apnea measures and a reduction in the rate of ear infections over 52 weeks. These findings complement previously reported primary and secondary endpoint results published in The New England Journal of Medicine, which demonstrated improved annual height velocity and body proportionality. BridgeBio has submitted an NDA to the FDA for infigratinib.