• 20 Aug 2024
• Admin
• News Article

Vericel Receives US FDA Approval For NexoBrid

Vericel receives US FDA approval for NexoBrid to treat paediatric patients with severe thermal burns

Overview

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, announced that the US Food and Drug Administration has approved a pediatric indication for NexoBrid (anacaulase-bcdb) for eschar removal in paediatric patients with deep partial-thickness and/or full-thickness thermal burns.

Words from the CEO: Vericel

• We are pleased that the US FDA approved NexoBrid for pediatric use as it provides a novel non-surgical solution for managing severe burn injuries in this vulnerable pediatric patient population,” said Nick Colangelo, President and CEO of Vericel. 
• We believe NexoBrid is poised to become the new standard of care for eschar removal and make a meaningful impact on the lives of adult and pediatric burn patients, and we look forward to further executing on our NexoBrid commercial launch.”

NexoBrid Pediatric Approval Study

• The US FDA approval of the pediatric indication for NexoBrid is based on the results of a global phase 3 clinical trial, Children Innovation Debridement Study (CIDS), which evaluated the safety and efficacy of NexoBrid in hospitalized pediatric patients, as well as additional paediatric data available from phase 3 and phase 2 studies conducted during the clinical development of NexoBrid. 
• Vericel is expanding its target customer base to include the approximately 20 paediatric burn centers in the United States, which the company expects will have a meaningful impact on overall NexoBrid uptake over time.

From the Burn Surgery Specialist

For pediatric burn patients, NexoBrid represents a less invasive alternative to traditional methods and the approval ensures that children will now have access to this innovative non-surgical option to quickly and effectively treat severe thermal burns,” said Steven Kahn, MD, chief of burn surgery at MUSC, University Hospital and Shawn Jenkins Children’s Hospital.

About NexoBrid

• NexoBrid was initially approved for eschar removal in adults with deep partial-thickness and/or full-thickness thermal burns by the US FDA on December 28, 2022, and is commercially available in the United States.
• NexoBrid (anacaulase-bcdb) is a biologic product containing proteolytic enzymes indicated for eschar removal in adults and pediatric patients with deep partial- and/or full-thickness thermal burns.