Posted by Michael Wonder on 30 Jun 2020
MediWound announces submission of biologics license application to the US FDA for NexoBrid for the treatment of severe thermal burns
30 June 2020 - MediWound today announced it has submitted a biologics license application to the US FDA seeking the approval of NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.
The submission includes a comprehensive set of manufacturing data, multiple preclinical and clinical studies including the pivotal U.S. Phase 3 (DETECT) study of NexoBrid in adult patients with deep partial and full-thickness thermal burns up to 30% of total body surface area.
