MediWound receives FDA approval for NexoBrid
pharmafile | January 3, 2023 | News story | Medical Communications |
Israeli biopharma company MediWound has secured FDA approval for its wound care product NexoBrid (anacaulase-bcdb). US-based biopharma company Vericel will hold the exclusive license to commercialise Nexobrid in North America.
NexoBrid is a non-surgical alternative for the treatment of severe burns. It is a bromelain-based biological product that contains a sterile mixture of proteolytic enzymes, which selectively remove burn eschar within four hours. It is indicated for adult patients with deep partial-thickness or full-thickness thermal burns.
NexoBrid’s approval was supported by the phase 3 DETECT study, which evaluated the product in patients with deep partial-thickness and full-thickness thermal burns of 3% to 30% of total body surface area (TBSA).
The study met its primary endpoint, which was complete eschar removal, and all secondary endpoints: shorter time to eschar removal and a lower incidence of eschar removal compared to standard of care (SOC).
MediWound chief executive officer Ofer Gonen said: “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 US. This US 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.”
Vericel president and CEO Nick Colangelo said: “There is a considerable unmet need for non-surgical eschar removal for patients with severe thermal burns, and the FDA’s approval of NexoBrid marks an important advancement in the treatment paradigm for these patients. The addition of NexoBrid to our commercial portfolio significantly expands our target addressable market, and we look forward to executing on our NexoBrid commercial launch plans and establishing NexoBrid as the new standard of care for eschar removal.”
For the development of NexoBrid, MediWound has received federal funding from the US Biomedical Advanced Research and Development Authority (BARDA). It will also receive $7.5 million in milestone payment from Vericel for receiving FDA approval.
James Spargo
