The U.S. Food and Drug Administration (FDA) has issued a response to the Biologics License Application (BLA) for investigational gene therapy, nadofaragene firadenovec, which was submitted by FKD Therapies Oy, the company leading the development and regulatory filing for the therapy.
In its response letter, the FDA indicated there are outstanding questions that our manufacturing partner needs to further address regarding its CMC and manufacturing processes. There are no outstanding questions regarding the clinical data for nadofaragene firadenovec. The application for nadofaragene firadenovec was granted Priority Review, Fast Track and Breakthrough Therapy Designations by the FDA.
We remain confident in the potential approval of nadofaragene firadenovec as a new treatment option for patients with high-grade, BCG-unresponsive non-muscle invasive bladder cancer based on the clinical data, and will continue to work closely with the FDA to address their response to the application. We are committed to bringing this novel gene therapy to patients in need as quickly as possible.