Israel-based biopharmaceutical company MediWound has received the US Food and Drug Administration (FDA) approval for its wound care product NexoBrid (anacaulase-bcdb).

NexoBrid is a bromelain-based biological product that contains a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours.

It is a non-surgical alternative for the treatment of severe burn injuries and is indicated for the removal of eschar in adults with deep partial-thickness or full-thickness thermal burns.

NexoBrid has already been approved in 43 countries, including the European Union (EU), Japan, India, and other markets worldwide.

US-based biopharmaceutical company Vericel holds an exclusive license to commercialise NexoBrid in North America.

With the FDA approval of NexoBrid, MediWound will receive $7.5m in milestone payment from Vericel.

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.”

MediWound said that the US FDA approval of NexoBrid is supported by multiple preclinical and clinical studies, including the Phase 3 DETECT study.

The US clinical study evaluated NexoBrid in adult patients with deep partial-thickness and full-thickness thermal burns of 3% to 30% of total body surface area (TBSA).

The Phase 3 DETECT study has met its primary endpoint of complete eschar removal.

It has also met all the secondary endpoints, including a shorter time to eschar removal and a lower incidence of surgical eschar removal compared to the standard of care (SOC).

The study also achieved a key safety endpoint, non-inferiority in time to >95% wound closure compared with patients treated with SOC, said the company.

MediWound has received federal funding from the US Biomedical Advanced Research and Development Authority (BARDA), for the development of NexoBrid.

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.”