The approval for the non-surgical alternative was supported by phase 3 data showing ≥95% incidence eschar removal compared to a gel vehicle.
The US Food and Drug Administration (FDA) has approved anacaulase-bcdb (NexoBrid) as a non-surgical alternative for the removal of eschar in adults with deep partial- or full-thickness thermal burns.
The approval, granted to biopharmaceutical tissue repair and regeneration company MediWound, marks the US as the 44th country to indicate use of NexoBrid for thermal burns—as it has already received regulatory approval in the European Union, India, Japan, and other regions.
The product’s Biologics License Application (BLA) submission was supported by evidence from 8 clinical trials, including the US phase 3 DETECT trial, in which anacaulase-bcdb’s efficacy and safety was assessed in adult patients with deep partial- and full-thickness thermal burns accumulating 3 – 30% of total body surface area (TBSA). In DETECT, the product met the primary endpoint of ≥95% incidence eschar removal compared to a gel vehicle. It additionally met all secondary endpoints including shorter time to eschar removal, lowered incidence of surgical eschar removal and less blood loss compared to standard of care.
Investigators additionally observed a safety outcome of non-inferiority in time to >95% wound closure among those treated with anacaulase-bcdb compared to standard of care.
In a statement accompanying the approval, Ofer Gonen, chief executive officer of MediWound, expressed excitement for the FDA approval, calling NexoBrid an “innovative, non-surgical alternative” for severe burn treatment.
“This FDA approval of NexoBrid validates our enzymatic technology platform. MediWound will continue to pursue its strategic plans to advance the development of novel therapies for burn care, wound care, and tissue repair; we look forward to an exciting and productive 2023,” Gonen said.
Lucy A. Wibbenmeyer, MD, Past President of the American Burn Association and clinical professor of Surgery-Acute Care Surgery in Iowa City, praised the product’s enabling of “fast and effective topical treatment for eschar removal.”
“I believe that NexoBrid could offer a paradigm shift in burn care and has the potential to become a standard of care in this significant market,” Wibbenmeyer said.