MediWound announces FDA accepted review the sBLA for NexoBrid

MediWound announced that the U.S. Food and Drug Administration, FDA, has completed their filing review and accepted a supplement to the NexoBrid biologics license application, sBLA, for the removal of eschar in pediatric patients with deep partial- and/or full-thickness thermal burns. The sBLA seeks to expand the label for NexoBrid to include both adult and pediatric burn patients of all ages. It is based on the results of a global Phase 3 clinical trial, Children Innovation Debridement Study, which evaluated the safety and efficacy of NexoBrid in hospitalized pediatric patients, as well as additional pediatric data available from Phase 3 and Phase 2 studies conducted during the clinical development of NexoBrid. “The acceptance of the NexoBrid sBLA filing by the FDA marks an important milestone for MediWound and reinforces our commitment to redefine the standard of care for the treatment of severe burns across all age groups,” said Ofer Gonen, CEO of MediWound. “NexoBrid is already approved for the adult and pediatric populations in Europe and Japan, and we look forward to working with the FDA, alongside our partner Vericel, throughout the sBLA review process.”