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MediWound Receives Positive CHMP Opinion Recommending Approval for NexoBrid® to Treat Pediatric Patients
The label expansion will solidify NexoBrid’s position in the EU as a safe and effective non-surgical treatment for burn patients of all ages YAVNE, Israel,
About this update from Mediwound Ltd.
[{"type":"text","content":"The label expansion will solidify NexoBrid’s position in the EU as a safe and effective non-surgical treatment for burn patients of all ages\nYAVNE, Israel, Nov. 13, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending a change to the terms of the marketing authorization for NexoBrid in Europe to include all age groups for removal of eschar in patients with deep partial- and full-thickness thermal burns. The CHMP positive opinion is pending a decision by the European Commission, which is expected imminently. This positive opinion is based on the results of a global Phase 3 trial that evaluated the safety and efficacy of NexoBrid in hospitalized pediatric patients (CIDS study), funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. It is also supported by additional pediatric data available from Phase 3 and Phase 2 studies conducted during the clinical development of NexoBrid. The Phase 3 study met its three primary endpoints with a high degree of statistical significance. NexoBrid demonstrated a significant reduction in the time to achieve complete eschar removal and a significant reduction in the wound area requiring surgical excision (surgical need) while demonstrating non-inferiority to SOC in quality of scars as measured by MVSS. The study also met certain secondary endpoints showing statistically significant reduction in the incidence of surgical excision and a reduction in the need for autograft in deep partial burns, as well as a favorable trend in the reduction of blood loss during the eschar removal process. In addition, the study confirmed NexoBrid to be safe and well-tolerated for all ages. “This significant milestone advances our goal to redefine the standard of care for the treatment of severe burns. The current standard, surgery, is extremely traumatic to both patients and their families. NexoBrid offers a safe, fast, and highly effective debridement alternative to surgery, minimizing blood loss and re...