Policy & Regulation
Humacyte's Biologics License Application for Human Acellular Vessel granted Priority Review by FDA
9 February 2024 -

Humacyte Inc (Nasdaq:HUMA), a clinical-stage biotechnology platform company, announced on Friday that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to its Biologics License Application (BLA) for the Human Acellular Vessel (HAV).

The HAV is intended for urgent arterial repair following extremity vascular trauma when synthetic grafts are not indicated and when autologous vein use is not feasible. The Prescription Drug User Fee Act (PDUFA) date for the regulatory decision is set for 10 August 2024, based on the Priority Review grant, which expedites review time to six months.

The BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial and real-world evidence from wartime injuries treated in Ukraine under a Humanitarian Aid Program. The HAV demonstrated higher rates of patency (blood flow), and lower rates of amputation and infection, compared to historic synthetic graft benchmarks.

Designed as a universally implantable vascular replacement, the HAV does not require immune suppression and resists infection after implantation. It has the potential to save time for surgeons, improve outcomes and reduce complications. Humacyte's manufacturing facilities have the capacity to provide thousands of vessels for patients in need, with over 1,200 patient-years of experience worldwide across multiple clinical trials.