The US FDA has approved NexoBrid for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns with expected availability in Q2’23 in the US
The approval was based on the pre-clinical & clinical studies, incl. the P-III study (DETECT) of NexoBrid. The study met its 1EPs of incidence of ≥95% eschar removal over gel vehicle & 2EPs incl. shorter time to eschar removal, lower incidence of surgical eschar removal, non-inferiority in time to >95% wound closure was achieved
NexoBrid was approved in 43 countries, incl. the EU, Japan, India & other international markets. Under the collaboration with Vericel, MediWound will receive a $7.5M milestones & Vericel holds an exclusive license to commercialize NexoBrid in North America
Ref: MediWound | Image: MediWound
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