Vericel announces FDA approval of NexoBrid for severe thermal burns

Vericel (VCEL) announced that the U.S. Food and Drug Administration has approved NexoBrid for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns. The FDA approval of NexoBrid is based on multiple preclinical and clinical studies, including the pivotal Phase 3 U.S. clinical study which evaluated NexoBrid in adult patients with deep partial-thickness and full-thickness thermal burns of 3%-30% of total body surface area. 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, including both surgical and non-surgical eschar removal methods. A key safety endpoint, non-inferiority in time to greater than95% wound closure compared with patients treated with SOC, was also achieved. NexoBrid is a registered trademark of MediWound (MDWD) and is used under license to Vericel Corporation