FDA Grants Priority Review to BridgeBio's Oral Infigratinib for Pediatric Achondroplasia

The U.S. Food and Drug Administration (FDA) has granted Priority Review to BridgeBio's New Drug Application (NDA) for oral infigratinib, an investigational once-daily treatment for pediatric achondroplasia. This designation accelerates the review process to a six-month period. The NDA is supported by data from the Phase 3 PROPEL 3 trial, which demonstrated a 2.1 cm per year gain in annualized height velocity over placebo in children aged 3 to 17. Infigratinib targets FGFR3 through a distinct mechanism and offers an oral alternative to current daily injectable treatments.