MediWound Announces FDA Approval of NexoBrid® for Treating Pediatric Severe Burns

In a landmark development, MediWound Ltd., a global leader in enzymatic therapeutics for tissue repair, announced that the U.S. Food and Drug Administration (FDA) has extended the approval of NexoBrid® (anacaulase-bcdb). This new approval allows the use of NexoBrid for eschar removal in children from newborns to 18 years old who suffer from deep partial- and/or full-thickness thermal burns. This decision aligns with its previous approvals in the European Union and Japan, thereby making NexoBrid universally applicable across all age groups in these regions.

The approval marks a significant achievement for MediWound's mission to enhance burn care. According to Ofer Gonen, Chief Executive Officer of MediWound, pediatric burn victims comprise over 30% of the total burn population, and the current surgical methods can be deeply traumatic for both the children and their families. "Since the initial approval of NexoBrid, our goal has been to extend its benefits to children, reflecting our long-term commitment to revolutionize burn treatment," Gonen stated.

The FDA's decision was backed by a global Phase III clinical trial named the Children Innovation Debridement Study (CIDS). This study assessed the safety and efficacy of NexoBrid in treating hospitalized pediatric patients. Additional data from earlier Phase III and Phase II trials also supported the submission. Importantly, the CIDS trial received funding from the Biomedical Advanced Research and Development Authority (BARDA), an entity within the U.S. Department of Health and Human Services.

NexoBrid is a topical biological product designed to enzymatically remove nonviable burn tissue, or eschar, without damaging healthy tissue. It is approved in over 40 countries, including significant markets such as the United States, European Union, and Japan. NexoBrid has been designated as an orphan biologic drug in these regions.

The development of NexoBrid has been significantly supported by federal funds from the U.S. Department of Health and Human Services, specifically under the Administration for Strategic Preparedness and Response, and BARDA. The funding and technical support facilitated the pivotal U.S. Phase 3 clinical study, known as DETECT, and the CIDS trial for the pediatric population. These resources also aided the marketing approval registration process and made NexoBrid available under the expanded access treatment protocol (NEXT).

MediWound Ltd., listed on Nasdaq under the ticker MDWD, specializes in developing next-generation enzymatic therapeutics aimed at non-surgical tissue repair. The company focuses on creating biologics that not only improve the standard of care but also enhance patient experiences and reduce unnecessary medical costs. The first drug developed by MediWound, NexoBrid®, is FDA and EMA-approved for the removal of eschar in deep partial-thickness and/or full-thickness thermal burns, offering a significant reduction in the need for surgical interventions.

In addition to NexoBrid, MediWound is advancing its research and development pipeline with EscharEx®, a biologic ready for Phase III trials aimed at the debridement of chronic wounds. EscharEx® promises substantial advantages over existing products in the market, which is valued at over $360 million, providing an opportunity to broaden market reach.

MediWound's achievements reflect its commitment to developing innovative solutions in wound care and burn treatment, offering safer and more effective alternatives to surgical procedures. The FDA approval for pediatric use of NexoBrid sets a new benchmark in the management and treatment of burns, promising better outcomes for young patients.