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uniQure/CSL’s EtranaDez Could Take Lead Position In Hemophilia B Gene Therapy Market

 
• By Alaric DeArment

The therapy could also face competition from players like Freeline, but new Phase III data position uniQure and CSL Behring well for planned FDA and EMA filings.

3-D Rendering Red Blood Cells
uniQure and CSL Behring announced positive Phase III data for EtranaDez in hemophilia B • Source: Shutterstock

After a delay in their original filing plans, uniQure N.V. and CSL Limited (CSL Behring) have come back with Phase III data on etranacogene dezaparvovec (EtranaDez) in hemophilia B that should be sufficient to seek US Food and Drug Administration approval for the gene therapy in the first half of 2022, in addition to opening up a significant commercial opportunity.

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