MediWound bags USFDA nod for NexoBrid to treat severe thermal burns in adults

NexoBrid is already approved for use in 43 countries, including the European Union, Japan, India, and other international markets. Vericel Corporation holds an exclusive license to commercialize NexoBrid in North America. MediWound will receive a $7.5 million milestone payment from Vericel Corporation, triggered by the FDA approval of NexoBrid.

The BLA submission leading to FDA approval covered by a comprehensive battery of pre-clinical studies and 8 clinical studies, including the pivotal Phase 3 U.S. clinical study (DETECT), which evaluated the efficacy and safety of NexoBrid in adult patients with deep partial-thickness and full-thickness thermal burns of 3%-30% of total body surface area (TBSA).

The study met its primary endpoint of incidence of ≥95% eschar removal compared to gel vehicle, as well as all secondary endpoints, including shorter time to eschar removal, lower incidence of surgical eschar removal, and lower blood loss compared to surgical and non-surgical standard of care (SOC), including both surgical and non-surgical eschar removal methods, with highly statistically significant results. A safety endpoint of non-inferiority in time to >95% wound closure compared with patients treated with SOC was also achieved. In addition, non-inferiority was established between NexoBrid and SOC in cosmesis and function of burn scars after 12- and 24-month follow-up. Overall, NexoBrid is safe and well tolerated.

NexoBrid can be applied in up to two applications of four hours each. A first application of NexoBrid may be applied to an area of up to 15% body surface area. A second application of NexoBrid may be applied 24 hours later, with a total treated area for both applications of up to 20% TBSA.