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Accelerated Assessment Success In EU For CSL Behring And Roche

EtranaDez Will Be And Mosunetuzumab Already Is On Fast-Track Review Pathway At EMA

 
• By Maureen Kenny

There have been some recent successes on the accelerated assessment front in the EU but more requests are rejected than granted. 

Investigational hemophilia B gene therapy EtranaDez has received EU fast track status • Source: Alamy

A further two investigational therapies have been granted accelerated assessment status in the EU. This brings to 11 the number of known successful applicants for this fast-track review mechanism at the European Medicines Agency this year to date. 

The two products are uniQure N.V./CSL Behring’s hemophilia B gene therapy candidate etranacogene dezaparvovec (CSL222/AMT-061 and also referred to as EtranaDez) and Roche’s mosunetuzumab for the treatment of adults...

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