NexoBrid FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 19, 2024.
FDA Approved: Yes (First approved December 28, 2022)
Brand name: NexoBrid
Generic name: anacaulase-bcdb
Dosage form: Lyophilized Powder for Topical Gel
Company: Vericel Corporation
Treatment for: Thermal Burns
NexoBrid (anacaulase-bcdb) is a concentrate of proteolytic enzymes indicated for eschar removal in adult and pediatric patients with deep partial thickness and/or full thickness thermal burns.
- Thermal burns are injuries caused by excessive heat, typically from contact with hot surfaces, hot liquids, steam, flame or flash, and electrical injury. Thermal burns cause both local injuries and, if severe (> 20% of body surface area), a systemic response from the release of inflammatory and vasoactive mediators.
- The enzymes contained in NexoBrid work in the treatment of thermal burns by dissolving burn wound eschar. Eschar refers to the black, thick and leathery nonviable layers of skin or tissue indicating deep partial or full thickness injury.
- NexoBrid should only be applied by trained healthcare professionals in specialist burn centres.
- NexoBrid powder is mixed with a gel vehicle to form a uniform medicated gel and then applied to a clean, keratin-free (blisters removed), and moist wound area.
- In adults, NexoBrid can be applied in up to two applications of four hours each. A first application may be applied to an area of up to 15% of 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% of body surface area.
In pediatric patients over six years of age, NexoBrid is applied in one application of 4 hours to an area of up to 15% of body surface area.
In pediatric patients less than six years of age, NexoBrid is applied in one application of 4 hours to an area of up to 10% of body surface area. - Warnings and precautions associated with NexoBrid include hypersensitivity reactions, management of pain during dressing changes, and coagulation abnormalities.
- Common adverse reactions include pruritus and pyrexia.
Development timeline for NexoBrid
| Date | Article |
|---|---|
| Aug 15, 2024 | Approval Vericel Announces FDA Approval of NexoBrid for the Treatment of Pediatric Patients with Severe Thermal Burns |
| Dec 29, 2022 | Approval FDA Approves NexoBrid (anacaulase-bcdb) for the Treatment of Severe Thermal Burns in Adults |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.