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)
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
