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FDA Grants Priority Review to Engineered Tissue for Vascular Replacement


The FDA has set a Prescription Drug User Fee Act date of Aug. 10, 2024, for Human Acellular Vessel to repair arteries in patients with extremity vascular trauma.

The FDA has granted priority review to Humacyte’s biologics license application (BLA) for Human Acellular Vessel (HAV), which would be used to repair arteries in patients with extremity vascular trauma when synthetic graft is not indicated. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of Aug. 10, 2024.

The HAV is a bioengineered tissue that is being researched as an implantable vascular replacement that does not require immune suppression. Designed to be ready for off-the-shelf use, the HAV can be produced at commercial scale in Humacyte’s existing manufacturing facilities.

The BLA, which was submitted in December 2023, is supported by positive results from the V005 phase 2/3 clinical trial, as well as real-world evidence from the treatment of wartime injuries in Ukraine under a Humanitarian Aid Program supported by the FDA. The V005 trial is a single-arm study conducted in the United States and Israel in patients with arterial injuries resulting from gun shots, workplace injuries, car accidents, or other traumatic events. The study enrolled 69 patients, and 51 had vascular injury of the extremities and comprised the primary evaluation group for the study

The V005 trial met its objectives, and the HAV demonstrated a higher 30-day secondary patency rate of 90.2% for the patients with extremity vascular trauma compared with 78.9% historically reported for synthetic grafts. Primary patency for the HAV was 84.3% for the patients with extremity vascular trauma, although no comparison to synthetic graft primary patency was possible since this measure was not reported in the benchmark publications.

The HAV also demonstrated lower amputation rates, with a rate of 9.8% for patients with extremity vascular trauma, compared with 24.3% historically reported for synthetic grafts. The HAV demonstrated lower rates of infection, with a rate of 2.0% for the V005 patients with extremity vascular trauma compared with 8.4% historically reported for synthetic grafts.

The FDA agreed that Humacyte could include data in the BLA submission from patient outcomes from a humanitarian program, study V017, conducted in Ukraine. The results for the 16 patients from Ukraine with extremity vascular trauma. This trial demonstrated 30-day primary and secondary patency of 93.8%, zero amputations, and zero cases of infection of the HAV.

“These results indicate that the HAV performed well in this vascular trauma population who were at a very high risk of limb loss due to the nature of their injuries,” Ernest E. Moore, M.D., director of Research at the Ernest E. Moore Shock Trauma Center at Denver Health and a clinical investigator in the V005 trial, said in a press release. “These results are most notable considering the high risk of wound infection and immediate availability of a durable conduit.”

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