UniQure: FDA Accepts BLA For Etranacogene Dezaparvovec For Priority Review

uniQure N.V. (QURE) announced the FDA has accepted for priority review the Biologics License Application submitted by CSL Behring for etranacogene dezaparvovec, an investigational gene therapy for the treatment of adults with hemophilia B.

CSL Behring is uniQure's global commercialization partner for etranacogene dezaparvovec. CSL Behring is solely responsible for all regulatory activities, including filings and agency interactions, associated with etranacogene dezaparvovec.

uniQure led the clinical development of etranacogene dezaparvovec, including the phase III HOPE-B clinical trial, and the company will be responsible for the global commercial supply of etranacogene dezaparvovec.

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