BOSTON and MONTRÉAL, Dec. 3, 2020 /PRNewswire/ – enGene Inc., a biotechnology company developing non-viral gene therapies for local administration into mucosal tissues enabled by its proprietary DDX platform, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to enGene for EG-70, the company’s lead investigational non-viral gene therapy for the treatment of patients with Bacille Calmette-Guerin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC).
The Fast Track program is intended to facilitate the development and expedite the review of therapies that treat serious conditions and fill an unmet medical need. Therapeutic programs that receive Fast Track Designation can benefit from more frequent communication with the FDA, eligibility for Priority Review and Accelerated Approval, and potentially for Rolling Review of the marketing application.
“Fast Track Designation underscores the urgent need for new and effective treatments for BCG-unresponsive NMIBC patients,” said Jason Hanson, Chief Executive Officer