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BridgeBio软骨发育不全资产因figratini获得FDA突破性治疗状态
2024-09-17 23:49
- The U.S. FDA has granted BridgeBio Pharma's (NASDAQ:BBIO) achondroplasia candidate infigratinib FDA Breakthrough Therapy Designation.
- The status provides for faster review of experimental drugs that are seen as having potentially significant improvement over currently approved therapies.
- The classification was granted based on results from a cohort of PROPEL 2 data, which showed infigratinib resulted in a statistically significant annual height velocity increase. The mean change from baseline was +2.51cm/yr at one year, and +2.50 cm/yr at 18 months.
- A statistically significant improvement in body proportionality at 18 months was also seen.
- PROPEL 3, a phase 3 trial, is enrolling, and is expected to finish enrollment by the end of the year.
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