MediWound bags USFDA nod for NexoBrid to treat severe thermal burns in adults
NexoBrid (anacaulase-bcdb) is indicated for eschar removal in adults with deep partial-thickness and/or full-thickness thermal burns
Yavne: MediWound Ltd. has 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 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 3 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).
The study met its primary endpoint of incidence of ≥95% eschar removal compared to gel vehicle, as well as all secondary endpoints, including shorter time to eschar removal, lower incidence of surgical eschar removal, and lower blood loss compared to surgical and non-surgical standard of care (SOC), including both surgical and non-surgical eschar removal methods, with highly statistically significant results. A safety endpoint of non-inferiority in time to >95% wound closure compared with patients treated with SOC was also achieved. In addition, non-inferiority was established between NexoBrid and SOC in cosmesis and function of burn scars after 12- and 24-month follow-up. Overall, NexoBrid is safe and well tolerated.
NexoBrid can be applied in up to two applications of four hours each. A first application of NexoBrid may be applied to an area of up to 15% body surface area. A second application of NexoBrid may be applied 24 hours later, with a total treated area for both applications of up to 20% TBSA.
