FDA approves pediatric indication for NexoBrid for treatment of thermal burns

Key takeaways:

• NexoBrid was approved for the treatment of deep partial-thickness and full-thickness thermal burns in adults in 2022.
• The approved indication has now been expanded to include pediatric patients.

The FDA has approved a pediatric indication for NexoBrid for the treatment of deep partial-thickness and full-thickness thermal burns, Vericel Corporation announced in a press release.

Originally approved in 2022 for eschar removal of deep partial-thickness and full-thickness thermal burns in adults only, NexoBrid (anacaulase-bcdb) is now indicated in the pediatric population as well.

“We are pleased that the FDA approved NexoBrid for pediatric use as it provides a novel nonsurgical solution for managing severe burn injuries in this vulnerable pediatric patient population,” Nick Colangelo, BSBA, JD, president and CEO of Vericel, said in the release.

“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,” Colangelo continued.

The biologic product, which contains proteolytic enzymes, was approved based on results from a phase 3 clinical trial that evaluated the efficacy and safety of NexoBrid for the treatment of pediatric patients hospitalized for thermal burns. Positive data from additional phase 3 and phase 2 studies were also used to support this approval.