MediWound has secured approval from the US Food and Drug Administration (FDA) for its NexoBrid (anacaulase-bcdb) treatment for eliminating eschar in adults with deep partial-thickness and/or full-thickness thermal burns.
A bromelain-based biological product, NexoBrid features a sterile mixture of proteolytic enzymes, which selectively eliminate burn eschar within four hours without causing harm to surrounding viable tissue.
Vericel has the exclusive license for the commercialisation of NexoBrid in North America.
The FDA approval of NexoBrid enables MediWound to receive a $7.5m milestone payment from Vericel.
The biologics license applications leading to the approval from the regulatory body are backed by a comprehensive set of pre-clinical studies as well as eight clinical studies, including a pivotal Phase 3 US clinical study called DETECT.
The DETECT trial assessed the efficacy and safety of NexoBrid in adult patients with deep partial-thickness or full-thickness thermal burns over 3% to 30% of their total body surface area (TBSA).
According to the company, the study achieved its primary endpoint of incidence of ≥95% eschar removal compared to gel.
Furthermore, it met all secondary endpoints, including a lower incidence of surgical eschar removal, shorter time to eschar removal and lower blood loss as against surgical and non-surgical standards of care.
MediWound CEO Ofer Gonen said: “We appreciate and thank the burn patients who participated in our trials, the clinical investigators, and our researchers for their commitment and efforts to attain this significant achievement.
“We also thank our partner, BARDA, for their unwavering support since 2015 and our commercial partner, Vericel, who will launch NexoBrid in the US.”
NexoBrid has already secured approval in 43 countries, including Japan, India, countries in the European Union and other international markets.