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EMA grants Jet Behring etranacogene dezaparvovec accelerated assessment status

 Last Update: 2022-02-24
 Source: Internet
 Author: User

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CSL Behring announced today that the European Medicines Agency (EMA) has approved a request for accelerated evaluation of the Marketing Authorization Application (MAA) for the hemophilia B gene therapy etranacogene dezaparvovec (EtranaDez)

Previously, etranacogene dezaparvovec has been granted Breakthrough Drug Designation (BTD) by the US FDA and Priority Drug Designation (PRIME) by the EMA

Recently, Jet Behring announced positive results from the pivotal Phase 3 HOPE-B trial

The study further showed that etranacogene dezaparvovec was well tolerated in the 53 patients involved in the 18-month follow-up, with more than 80% of adverse events considered mild

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