Mediwound Ltd (MDWD)

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MediWound Announces U.S. Food and Drug Administration Approval of NexoBrid® for the Treatment of Pediatric Patients with Severe Thermal Burns

https://finance.yahoo.com/news/mediwound-announces-u-food-drug-201500706.html

Approval Helps Solidify NexoBrid’s Position in the U.S. as a Safe and Effective Non-Surgical Burn Treatment for All Ages

YAVNE, Israel, Aug. 15, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the U.S. Food and Drug Administration (FDA) has approved a pediatric indication for NexoBrid® (anacaulase-bcdb) allowing for eschar removal in pediatric patients aged newborn through eighteen with deep partial- and/or full-thickness thermal burns. With this FDA approval, NexoBrid is now authorized for use in the U.S. for all age groups, aligning with its approvals in the European Union and Japan.

“Today's announcement marks a significant milestone in our mission to improve burn care with NexoBrid,” said Ofer Gonen, Chief Executive Officer of MediWound. “Pediatric burn victims represent over 30% of the total burn population, and the current surgical standard of care can be extremely traumatic for both patients and their families. Since NexoBrid's initial approval, we have been dedicated to expanding its use to children, reflecting our long-term commitment to revolutionizing burn care.”

The submission was supported by the results of a global Phase III clinical trial, Children Innovation Debridement Study (CIDS), which evaluated the safety and efficacy of NexoBrid in hospitalized pediatric patients, as well as additional pediatric data available from Phase III and Phase II studies conducted during the clinical development of NexoBrid. Of note, the CIDS trial was funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services.