FDA approves NexoBrid for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns. Vericel + MediWound Ltd/Teva.
MediWound Ltd. a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, announced that the FDA has approved NexoBrid (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.
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 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 FDA approval covered by a comprehensive battery of pre-clinical studies and 8 clinical studies, including the pivotal Phase III U.S. clinical study (DETECT), which evaluated the efficacy and safety of NexoBrid in adult patients with deep partial-thickness and full-thickness thermal burns of 3%-30% of total body surface area (TBSA).
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