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MediWound Announces FDA Approval of NexoBrid® for the Treatment of Severe Thermal Burns in Adults
Potential to become the new standard of care for eschar removal in patients with deep partial- and/or full- thickness thermal burns Triggers $7.5 million
About this update from Mediwound Ltd.
[{"type":"text","content":"Potential to become the new standard of care for eschar removal in patients with deep partial- and/or full- thickness thermal burns Triggers $7.5 million milestone payment from Vericel Corporation; NexoBrid is anticipated to be commercially available in the U.S. in the second quarter of 2023 YAVNE, Israel, Dec. 29, 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 U.S. Food and Drug Administration (FDA) has approved NexoBrid® (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns. “We are pleased and excited that the FDA has approved NexoBrid, an innovative, non-surgical alternative for the treatment of severe burn injuries,” said Ofer Gonen, Chief Executive Officer of MediWound. “We appreciate and thank the burn patients who participated in our trials, the clinical investigators, and our researchers for their commitment and efforts to attain this significant achievement. We also thank our partner, BARDA, for their unwavering support since 2015, and our commercial partner, Vericel, who will launch NexoBrid in the U.S. This U.S. FDA approval of NexoBrid validates our enzymatic technology platform. MediWound will continue to pursue its strategic plans to advance the development of novel therapies for burn care, wound care, and tissue repair; we look forward to an exciting and productive 2023.” Past President of the American Burn Association, Lucy A. Wibbenmeyer, MD, Clinical Professor of Surgery-Acute Care Surgery, Iowa City, IA added, “NexoBrid enables fast and effective topical treatment for eschar removal in patients with second- and third-degree thermal burns. I believe that NexoBrid could offer a paradigm shift in burn care and has the potential to become a standard of care in this significant market.” NexoBrid is already approved for use in 43 countries, including the European Union, Japan, India, and other international markets. Vericel Corporation (Nasdaq: VCEL) holds an exclusive license to commercialize NexoBrid in North America. MediWound will receive a $7.5 million milestone payment from Vericel Corporation, triggered by the FDA approval of NexoBrid. The BLA submission leading to ...