FDA accepts BLA for etranacogene dezaparvovec

The US Food and Drug Administration has accepted for priority review the Biologics License Application (BLA) submitted by CSL Behring, a subsidiary of Australia’s CSL Limited (ASX: CSL), for etranacogene dezaparvovec, an investigational gene therapy for the treatment of adults with hemophilia B.

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

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