The US Food and Drug Administration (FDA) has extended the time needed to review clinical-stage biotechnology company Humacyte’s biologic license application (BLA) for its implant, the Acellular Tissue-Engineered Vessel (ATEV).
The FDA's decision extends the review process beyond the previously assigned Prescription Drug User Fee Act (PDUFA) date of 10 August 2024.
Humacyte submitted the BLA for ATEV in December 2023 and received priority review status from the FDA in February 2024.
The application included positive outcomes from the pivotal Phase II/III V005 clinical study and real-world evidence from the treatment of wartime injuries in Ukraine under a humanitarian aid programme.
A first-in-class bioengineered human tissue, the ATEV is designed for universal implantation in arterial replacement and repair.
Humacyte CEO Laura Niklason said: “FDA leadership noted that Humacyte’s ATEV is a first-in-class product, and that Priority Review had been granted, which allows only a six-month review cycle, as compared to the standard ten-month review cycle for most products.
“During the course of the BLA review, the FDA has conducted inspections of our manufacturing facilities and clinical sites and has actively engaged with us in multiple discussions regarding our BLA filing, including post-marketing and labeling discussions. Based on these interactions, we are confident in the approvability of the ATEV in treating vascular trauma.
“The FDA leadership expressed an apology for their inability to complete the review by the PDUFA date, and currently we do not yet have a revised action date.”
The ATEV offers a significant advantage in trauma surgery by being immediately available, eliminating the need to harvest veins from the patient, thus saving surgical time and reducing patient injury.
Its use spans a range of traumatic injuries, including those from gunshot and blast wounds, as well as car and industrial accidents.
It has been employed by surgeons in Level one Trauma centres across the US and Israel, as well as in Ukrainian hospitals.
Clinical studies have shown the ATEV to maintain high rates of patency and exhibit low rates of amputation and infection.
