The U.S. Food and Drug Administration has designated Humacyte Inc.'s HumaGraft development program for vascular access in hemodialysis patients as a Fast Track Development Program. HumaGraft is being developed to provide a vascular access alternative for hemodialysis patients to reduce or avoid certain serious complications associated with current forms of vascular access.
“The fast track designation for HumaGraft recognizes the significant unmet need that exists and provides options for vascular access in hemodialysis patients," Carrie Cox, Humacyte chairman and CEO. "We will continue to work closely with the FDA to ensure the most efficient review process as we advance the development of HumaGraft for patients needing hemodialysis access.”
Fast Track designation means that the FDA will take actions to facilitate the development and review of the product for the designated medical use. Fast Track Development Programs are eligible for more frequent meetings and written correspondence with FDA, for priority review if relevant criteria are met at the time when an application for approval is submitted, and potentially for “rolling review,” under which parts of the application may be accepted earlier than usual.
Humacyte recently announced that it has completed recruitment for two Phase I and II studies, one in Europe and one in the United States, for HumaGraft as a vascular access for hemodialysis. A separate investigational trial involving 20 patients with peripheral arterial disease who received a HumaGraft implant as a femoropopliteal bypass is fully enrolled and ongoing in Poland.