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BridgeBio对因菲格拉替尼治疗软骨发育不全进行了优先审查

2026-10-06 22:53

The US FDA accepted BridgeBio Pharma's (BBIO) NDA for oral infigratinib for achondroplasia and granted the application Priority Review. The FDA action date is Feb. 4, 2027.
The NDA is supported by results from the phase 3 PROPEL 3 trial in children with the condition. The study met its primary goal, change from baseline in annualized height velocity (AHV) at Week 52, as well as a key secondary endpoint, change from baseline in height Z-score.
Infigratinib is also under development for hypochondroplasia.

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