MediWound Ltd. has announced that NexoBrid (anacaulase-bcdb), a treatment for adults with deep partial- or full-thickness thermal burns, has been approved by the U.S. Food and Drug Administration (FDA) for the removal of eschar.
MediWound’s chief executive officer, Ofren Gonen, said that the FDA’s approval of NexoBrid, an innovative non-surgical treatment for severe burn injuries, makes them happy and excited. He went on to say that they are grateful to the burn patients who took part in our trials, the clinical investigators, and our researchers for their dedication and efforts in achieving this significant milestone.
MediWound also thank its partner BARDA, for their unwavering support since 2015, and Vericel, commercial partner of MediWoudn, for launching NexoBrid in the United States. The FDA’s approval of NexoBrid demonstrates the validity of their enzymatic technology platform. MediWound will continue to implement its strategic plans to advance the creation of novel therapies for the treatment of wounds, burns, and tissue repair, and the company also anticipate an exciting and productive year in 2023.
Patients with second-degree and third-degree thermal burns can get fast and effective topical treatment for eschar removal with NexoBrid. NexoBrid has the potential to become a standard of care in this significant market and is thought to offer a paradigm shift in burn care.
NexoBrid is as of now endorsed for use in 43 nations, including the European Association, Japan, India, and other worldwide business sectors. NexoBrid’s exclusive North American licensing is held by Vericel Corporation. Following NexoBrid’s FDA approval, MediWound will receive a $7.5 million milestone payment from Vericel Corporation.
The comprehensive battery of pre-clinical studies and eight clinical studies included in the BLA submission that resulted in FDA approval covered NexoBrid’s efficacy and safety in adult patients with deep partial-thickness and full-thickness thermal burns of 3 percent to 30 percent of the total body surface area.
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