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Humacyte Reports BLA Acceptance with Priority Review by the US FDA for Human Aacelluar Vessel to Treat Vascular Trauma

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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

Related News:- BMS Reports the Acceptance of its sBLA for Opdivo Combination Therapy by the US FDA and EMA for the Treatment of Non-Small Cell Lung Cancer (NSCLC)

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Click here to­ read the full press release 

Shivani Chandra

Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.

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