DURHAM, N.C. - The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to Humacyte, Inc.'s (NASDAQ:HUMA) Biologics License Application (BLA) for the Human Acellular Vessel (HAV), a bioengineered human tissue designed for urgent arterial repair following extremity vascular trauma. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date for August 10, 2024, which is the deadline for their regulatory decision on the BLA.
The Priority Review status accelerates the review time from ten months to six months and is typically awarded to therapies that could significantly improve the treatment of serious conditions. The HAV has also been recognized by the U.S. Secretary of Defense for its potential to treat vascular trauma, aligning with the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation granted in May 2023.
The BLA submission is based on findings from the V005 Phase 2/3 clinical trial and real-world evidence from the treatment of wartime injuries in Ukraine under a Humanitarian Aid Program. The HAV demonstrated higher rates of patency—meaning effective blood flow—and lower rates of amputation and infection compared to traditional synthetic graft benchmarks.
Humacyte's CEO, Laura Niklason, M.D., Ph.D., expressed satisfaction with the FDA's acceptance of the BLA, highlighting the potential of HAV technology to offer an innovative solution for patients with traumatic vascular injuries who are not adequately served by current standards.
The investigational HAV aims to provide a universally implantable vascular replacement that does not require immune suppression and is resistant to infection post-implantation. It is designed to be readily available for surgeons, potentially saving time and improving patient outcomes. Humacyte's existing manufacturing facilities are expected to produce thousands of vessels to meet patient needs.
This article is based on a press release statement from Humacyte, Inc.
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