FDA Accepted New Drug Application for Infigratinib
The drug targets children with achondroplasia and has been granted Priority Review for a 2027 decision.
Updated on Oct. 6, 2026 in Biotech
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The FDA has accepted the New Drug Application for oral infigratinib, a potential treatment for children with achondroplasia. The regulatory agency granted the application Priority Review with a target action date set for February 4, 2027.
Why it matters
The FDA granted Priority Review because of the significant unmet need for an oral therapeutic option for children with achondroplasia. Oral infigratinib works by inhibiting FGFR3 signaling to improve bone growth in patients affected by the activating variant.
The Phase 3 PROPEL 3 study measured a mean treatment difference of +2.10 cm/year in annualized height velocity at 52 weeks. The therapy targets an estimated 10,000 children and adolescents with achondroplasia who have open growth plates.
The players
FDA
The Food and Drug Administration is the federal agency responsible for protecting public health by ensuring the safety and efficacy of human drugs.
BridgeBio
This Palo Alto-based biopharmaceutical company focuses on developing medicines for genetic diseases and is the sponsor of the infigratinib clinical program.
EMA
The European Medicines Agency is a decentralized agency of the European Union responsible for the scientific evaluation and supervision of medicines.
The details
The drug is being developed to address the genetic cause of achondroplasia, which is an activating variant in the FGFR3 gene. BridgeBio plans to launch the medication in the United States upon approval and intends to submit a Marketing Authorization Application to the EMA in late 2026.
Timeline
Patients in the study were measured at 52 weeks.
BridgeBio plans to submit an MAA to the EMA in Q4 2026.
The FDA set a target action date of February 4, 2027.
The Tech Race
The development of oral infigratinib represents a significant shift toward targeted oral therapies for genetic bone growth disorders. This moves the industry away from historical reliance on injectable treatments for conditions involving FGFR3 variants.
Families could eventually gain access to an oral treatment alternative to existing injectable options for achondroplasia. Approval would introduce a new therapeutic daily regimen for the estimated 10,000 children with open growth plates globally.
The takeaway
This regulatory milestone brings a potential new oral treatment closer to patients suffering from achondroplasia. Continued tracking of the February 2027 decision will be essential for families seeking new long-term care options.
Further reading
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