FDA approves NexoBrid as therapy for severe burns

The US Food and Drug Administration (FDA) has approved NexoBrid (anacaulase-bcdb) as therapy for severe burns. It has potential to become the new standard of care for eschar removal in patients with deep partial- and/or full- thickness thermal burns.

“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,” said Nick Colangelo, President and CEO of Vericel. “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.”

The FDA approval of NexoBrid is based on multiple preclinical and clinical studies, including the pivotal Phase 3 U.S. clinical study (DETECT) which evaluated 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 complete eschar removal as well as all secondary endpoints, including shorter time to eschar removal and a lower incidence of surgical eschar removal compared to standard of care (SOC), including both surgical and non-surgical eschar removal methods. A key safety endpoint, non-inferiority in time to >95% wound closure compared with patients treated with SOC, was also achieved.

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.“

When treating partial- and full-thickness burns, a critical first step is the rapid removal of eschar and I believe the approval of NexoBrid provides us with an important non-surgical option to quickly and effectively treat severe thermal burns,” said Jeremy Goverman, MD, Massachusetts General Hospital. “As a principal investigator in the Phase 3 DETECT clinical trial, I look forward to further incorporating NexoBrid into my practice, as I believe it will lead to improved outcomes for my patients.”