Takeaways:
- FDA accepted a supplemental Biologics License Application (sBLA) for pediatric use of NexoBrid in deep partial/full-thickness thermal burns.
- NexoBrid enzymatically removes nonviable burn tissue and has been approved for adult thermal burn patients.
- Studies across three phases involving 110 children showed NexoBrid achieving complete eschar removal within 0.9 days.
- Long-term follow-up studies revealed favorable scar quality and improved quality of life in NexoBrid-treated pediatric patients.
- Potential FDA approval for pediatric use could significantly impact the treatment landscape, especially in preventing aggressive scarring in children.
On January 10, 2024, a supplemental Biologics License Application (sBLA) for NexoBrid (MediWound) was accepted by the FDA for the removal of eschar in pediatric patients with deep partial/and or full-thickness thermal burns.1
The topical biologic drug enzymatically removes nonviable burn tissue. Should it be approved by the FDA, the sBLA would expand to the pediatric indication, following the FDA approval of NexoBrid for adult thermal burn patients in December 2022. Currently, NexoBrid is approved in over 40 countries including the United States (adults), Japan, and the European Union.1
According to a 2020 study published in International Wound Journal, NexoBrid was evaluated in children across 3 consecutive studies, including a phase 1/2 study, a phase 3 randomized controlled trial (RCT), and a long-term phase 3b study.2
Across the 3 trials, 110 children aged 6 months to 18 years were treated with NexoBrid. These children and adolescents had deep thermal burns of up to 67% total body surface area. A total of 77 children were treated with NexoBrid in the phase 1/2 study, where 92.7% of areas treated developed “complete eschar removal within 0.9 days from admission.”2
In the phase 3 RCT, 33 children were included, 17 of which were treated with NexoBrid compared to 16 that received standard of care. All wounds that were treated with NexoBrid achieved complete eschar removal, with a time of 0.9 days for complete removal for NexoBrid (compared to 6.5 days for standard of care [P < .001]).2
Seventeen children participated in a phase 3b follow-up study, where 9 received NexoBrid and 8 received standard of care. In this study, long-term endpoints were measured by assessors masked to original treatment, 2 to 4 years after the injury. Endpoints were scar quality and quality of life.2
The investigative team noted long-term modified Vancouver Scar Scale scores were 3.4 for NexoBrid-treated wounds vs 4.4 for standard of care-treated wounds. No significant treatment-related adverse events were recorded.2
To further explain the potential benefits of NexoBrid in the pediatric population, Stan Monstrey, former head of the Plastic Surgery Clinic and Burn Center, Ghent University Hospital, Ghent, Belgium; former Secretary General, president, European Association of Plastic Surgeons, spoke with Contemporary Pediatrics in a Q+A interview:
Contemporary Pediatrics:
How could a potential FDA approval of NexoBrid change the treatment landscape in the United States, with your experience using NexoBrid in Europe?
Monstrey:
When it comes to achieving optimal outcomes after burn injury, the pediatric indication is even more important than the adult indication. This is because there is a well-known phenomenon that children often develop more aggressive and intense scarring than adults from the same depth of burns.
In pediatric patients we know that there will be increased scar tissue formation, so it is even more necessary to prevent and reduce the residual burn scars. Most importantly, children must live the rest of their lives with these sometimes unsightly scars. An 80-year-old with a facial scar resulting from a burn may be less impacted than a young girl with that same scar.
We are convinced, and this has been confirmed in the literature as well as in our own clinical experience, that the scar-reducing capacities of Nexobrid are even more important in pediatric patients to increase the quality of life after burn injury.
Contemporary Pediatrics:
How important can a topical treatment like this be, especially for this pediatric indication?
Monstrey:
NexoBrid substantially reduces the number of operations after burns. Previously, when treating deep thermal burns, it was common practice to perform tangential excision to attain a well-vascularized surface for skin grafting but this technique inevitably resulted in excessive removal of valuable healthy tissue. With this surgical procedure, the residual healing capacity is lowered, with substantially increased scarring. However, with Nexobrid we now have evidence that enzymatic debridement attains better results for our patients with less surgery, less donor sites, and notably fewer hypertrophic scars and contractures which increases the quality of life after burn injuries. The advantages that we've seen in Europe also stand to benefit US burn clinics, and of course US patients and their families.
References:
- Fitch, J. FDA accepts sBLA for NexoBrid to remove eschar in pediatric thermal burn patients. Contemporary Pediatrics. January 10, 2024. Accessed January 24, 2024. https://www.contemporarypediatrics.com/view/fda-accepts-sbla-for-nexobrid-to-remove-eschar-in-pediatric-thermal-burn-patients
- Shoham Y, Krieger Y, Rubin G, et al. Rapid enzymatic burn debridement: A review of the paediatric clinical trial experience. Int Wound J. 2020;17(5):1337-1345. doi:10.1111/iwj.13405
