FDA accepts sBLA for NexoBrid to remove eschar in pediatric thermal burn patients

NexoBrid, a topical biologic drug that enzymatically removes nonviable burn tissue, is 1 step closer to being FDA-approved for a pediatric indication after the FDA accepted a supplemental Biologics License Application for the removal of eschar in pediatric patients with deep partial and/or full-thickness thermal burns.¹

NexoBrid received FDA approval for eschar removal in adult patients in December 2022. With the sBLA, MediWound seeks an expanded label to include both adult and pediatric patients of all ages.¹

Currently, NexoBrid is approved in over 40 countries including the United States, European Union, and Japan.¹

The FDA’s acceptance of the sBLA is based on results from the phase 3 Children Innovation Debridement Study (CIDS) that evaluated efficacy and safety of NexoBrid in hospitalized pediatric patients.¹

Additional pediatric data was available from phase 3 and phase 2 studies that were conducted amid the development of NexoBrid.¹

According to ClinicalTrials.gov, “A study to evaluate the efficacy and safety of NexoBrid in children with thermal burns compared the standard of care,” (phase 3; NCT02278718) is a 2-arm study intending to demonstrate superiority of NexoBrid treatment over standard of care for children with thermal burns.²

The study enrolled 145 participants with the following age distributions:

• Aged 0 to 23 months: 45 patients
• Aged 24 months to 3 years: 45 patients
• Aged 4 to 11 years: 30 patients
• Aged 12 to 17 years: 20 patients

The remaining 20 patients were enrolled to any of the above groups, per their age during enrollment, the website states.²

The study was to be conducted in 3 stages, with the first including at least 24 children aged 4 to 18 years, hospitalized in burn units with deep partial thickness burns ranging from 1% to 30% total body surface area (TBSA).²

The CIDS trial was funded by the Biomedical Advanced Research and Development Authority, part of the US Department of Health and Human Services Administration for Strategic Preparedness and Response.¹

References:

1. MediWound announces that FDA has accepted for review the supplement to the NexoBrid BLA to include pediatric patients with severe thermal burns. MediWound. Press release. January 9, 2024. Accessed January 9, 2024. https://www.globenewswire.com/news-release/2024/01/09/2806137/30505/en/MediWound-Announces-that-FDA-has-Accepted-for-Review-the-Supplement-to-the-NexoBrid-BLA-to-Include-Pediatric-Patients-with-Severe-Thermal-Burns.html
2. A study to evaluate the efficacy and safety of NexoBrid in children with thermal burns compared the standard of care. ClincialTrials.gov. Updated July 27, 2022. Accessed January 9, 2024. https://clinicaltrials.gov/study/NCT02278718?term=NexoBrid&rank=2