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辉瑞血友病B基因疗法Durveqtix获得欧盟委员会授权
2024-07-26 00:13
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- The European Commission has granted conditional marketing authorization to Pfizer's (NYSE:PFE) gene therapy Durveqtix (fidanacogene elaparvovec) as a one-time treatment for hemophilia B.
- Authorization was based on results of the phase 3 BENEGENE-2 trial that met its primary efficacy endpoint of non-inferiority to multiple factor IX infusions as well as a statistically significant decrease in annualized bleeding rate versus regular FIX infusions.
- The drug is already approved in the U.S. and Canada under the name Beqvez.
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