Humacyte Reports BLA Acceptance with Priority Review by the US FDA for Human Aacelluar Vessel to Treat Vascular Trauma
Shots:
- The BLA submission was based on the results from the P-II/III (V005) trial of HAV along with the real-world evidence from the treatment of Ukraine war injuries under a Humanitarian Aid Program supported by the FDA
- Under evaluation, HAV depicted a higher rate of patency (blood flow) & a lower rate of amputation & infection vs historic synthetic graft benchmarks. The US FDA assigned a PDUFA date of Aug 10, 2024
- HAV, a bioengineered tissue, is being assessed as a universally implantable vascular replacement that does not require immune suppression & resists infection post-implantation. Additionally, HAV received the US FDA’s RMAT designation in May 2023 & Priority Designation by the Secretary of Defense under Public Law 115-92
Ref: Humacyte | Image: Humacyte
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
