FDA grants BridgeBio priority review for oral infigratinib in children with achondroplasia
BridgeBio Pharma announced that the FDA has accepted its New Drug Application for oral infigratinib and placed it on Priority Review, with a PDUFA target action date of February 4, 2027. The decision follows the Phase 3 PROPEL 3 trial, which met its primary endpoint and key secondary endpoints, showing a +2.10 cm/yr increase in annualized height velocity and improvements in body proportionality. BridgeBio said it is prepared to launch the drug in the U.S. if approved and will file a European marketing application in Q4 2026. The company highlighted additional favorable trends in sleep apnea and ear‑infection measures.
Why it matters
The company expects to launch oral infigratinib in the United States upon approval, which would make it the first oral therapy for pediatric achondroplasia (the company statement). The FDA’s Priority Review shortens the decision timeline, potentially accelerating revenue and providing a new treatment option for families.
Key facts
- 1The FDA accepted BridgeBio’s NDA for oral infigratinib and granted Priority Review. globenewswire.com
- 2The PDUFA target action date is February 4, 2027. globenewswire.com
- 3PROPEL 3 met its primary endpoint with a treatment effect of +2.10 cm per year in annualized height velocity (p<0.0001). rttnews.com
- 4PROPEL 3 also met its key secondary endpoint of change in height Z‑score (p<0.0001). rttnews.com
- 5In children under 8, the trial showed statistically significant improvements in body proportionality and arm‑span Z‑score. rttnews.com
- 6BridgeBio plans to submit a Marketing Authorization Application to the EMA in the fourth quarter of 2026. globenewswire.com
Summary written by AlphAI from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.