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EMA Accepts MediWound’s Application for Extended Indication for NexoBrid to Treat Pediatric Patients with Severe Thermal Burns
Upon approval, NexoBrid will serve as a safe and effective non-surgical treatment option in the EU for children with severe burns YAVNE, Israel, Sept. 20,
About this update from Mediwound Ltd.
[{"type":"text","content":"Upon approval, NexoBrid will serve as a safe and effective non-surgical treatment option in the EU for children with severe burns\nYAVNE, Israel, Sept. 20, 2022 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ: MDWD) (the “Company”), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced that the European Medicines Agency (EMA) has validated for review the Type II Variation submitted by MediWound in order to expand the current approved indication for NexoBrid (removal of eschar in adults with deep partial-and full-thickness thermal burn wounds) into the pediatric population. MediWound expects a decision from the European Commission in the first quarter of 2023. EMA has initiated evaluation of the application to extend the use of NexoBrid to children aged newborn through eighteen. The submission is supported by the interim results of a global, Phase 3 trial (CIDS - Children Innovative Debridement Study), evaluating the safety and efficacy of NexoBrid in hospitalized pediatric patients, and by additional data available from children who participated in the EU phase 3 study (MW2004-11-02) and phase 2 studies conducted during the clinical development of NexoBrid. “Today’s announcement reflects our long-term commitment to elevating burn care to a higher dimension. Adding pediatric burn victims is significant as they comprise more than 30% of the total burn population. The current standard of care is extremely traumatic to patients, as well as their families. NexoBrid enables clinicians to provide a safe, fast, and highly effective debridement option, independent of surgery, that addresses an unmet need in burn care, especially in the pediatric population,” said Ofer Gonen, Chief Executive Officer of MediWound. In July 2021, MediWound announced the results from the CIDS trial, a Phase 3, multinational, randomized, multicenter, open label, controlled, 2 arm study performed in children with deep partial thickness and full thickness thermal burns of 1% to 30% of total body surface area (TBSA). Top line Results demonstrated that the CIDS study successfully met its primary endpoint and secondary endpoints with a comparable safety profile to the standard of care. NexoBrid safety profile in children is consistent with the safety profile in adults. Patient...