Humacyte Inc (Nasdaq:HUMA), a clinical-stage biotechnology platform company, announced on Friday that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to its Biologics License Application (BLA) for the Human Acellular Vessel (HAV).
The HAV is intended for urgent arterial repair following extremity vascular trauma when synthetic grafts are not indicated and when autologous vein use is not feasible. The Prescription Drug User Fee Act (PDUFA) date for the regulatory decision is set for 10 August 2024, based on the Priority Review grant, which expedites review time to six months.
The BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial and real-world evidence from wartime injuries treated in Ukraine under a Humanitarian Aid Program. The HAV demonstrated higher rates of patency (blood flow), and lower rates of amputation and infection, compared to historic synthetic graft benchmarks.
Designed as a universally implantable vascular replacement, the HAV does not require immune suppression and resists infection after implantation. It has the potential to save time for surgeons, improve outcomes and reduce complications. Humacyte's manufacturing facilities have the capacity to provide thousands of vessels for patients in need, with over 1,200 patient-years of experience worldwide across multiple clinical trials.
Renew Biotechnologies names new chief operating officer
Teva, Sanofi accelerate inflammatory bowel disease drug trial
Ro adds David B Allison to Advisory Board
Charles River Laboratories and Autobahn Labs forge alliance to boost academic drug discovery
Nkarta partnering with Columbia on investigator-led lupus trial for NKX019
Gilead's lenacapavir demonstrates 100% efficacy in HIV prevention trial
Anixa Biosciences' ovarian cancer CAR-T therapy individual patient IND receives FDA approval
Evergreen Nephrology names new director
Emmaus Life Sciences names new chief executive officer
FDA feedback boosts Diamyd Medical's pathway to accelerated approval for Type 1 Diabetes Therapy
TC BioPharm (Holdings) doses sixth patient in TCB-008 clinical trial
Caidya names new chief executive officer
Ionis Pharmaceuticals reports positive results for ION582 in Angelman syndrome study
Nuvalent launches HEROEX-1 trial for HER2-selective inhibitor NVL-330
Astellas and Osaka University collaborate on stem cell therapy for disc degeneration