BridgeBio Announces FDA Acceptance and Priority Review of NDA for Oral Infigratinib for Children with Achondroplasia

The US Food and Drug Administration (FDA) accepted BridgeBio's new drug application (NDA, a request to approve a medicine) for oral infigratinib for children with achondroplasia, a condition affecting bone growth. The FDA granted the application Priority Review, an FDA designation that gives a shorter review timeline.

Key details

• The FDA's target action date under PDUFA (the date by which the agency aims to decide) is February 4, 2027.
• BridgeBio says its late-stage (Phase 3) clinical trial named PROPEL 3 met its primary endpoint and key secondary endpoints.
• BridgeBio describes +2.10 cm/yr as the treatment effect on AHV (annualized height velocity, the yearly growth rate) in PROPEL 3.
• BridgeBio says that, if approved, oral infigratinib would be the first and only approved oral therapy for children with achondroplasia.

What’s still pending

• Oral infigratinib is not yet approved; an FDA decision is targeted for February 4, 2027.

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