FDA Approves Non-Surgical Treatment for Severe Thermal Burns in Children
NexoBrid, a biological product that can be applied topically, has been approved for use in all age groups in the United States, European Union, and Japan
MediWound, a company based in Yavne, Israel, announced on Aug. 15, 2024, that their product NexoBrid (anacaulase-bcdb) has received FDA approval for treating deep partial and/or full-thickness thermal burns in pediatric patients. The FDA made its decision after reviewing the findings of a global Phase III clinical trial called the Children Innovation Debridement Study (CIDS). This trial was funded by the Biomedical Advanced Research and Development Authority, a division of the Administration for Strategic Preparedness and Response at the United States Department of Health and Human Services. The trial incorporated data from previous Phase III and Phase II studies.
NexoBrid is applied directly to the affected area, as stated by MediWound, and it effectively eliminates nonviable burn tissue, commonly referred to as eschar, while preserving healthy tissue. It has received orphan biologic drug designation in over 40 countries. With its recent approval in the United States for children from newborns to 18 years old, it can now be used on burn patients of all ages in the US, the European Union, and Japan.
MediWound is dedicated to creating and promoting fast-acting biologics that are highly efficient in aiding tissue repair without the need for surgery. The company has its European headquarters located in Rüsselsheim, Germany, while its US base is in Wilmington, Delaware.
"Today's announcement is a major step forward in our efforts to enhance burn care with NexoBrid," stated Ofer Gonen, CEO of MediWound, in the press release. Children who have suffered burns make up more than 30% of all burn cases, and the current surgical procedure can be very distressing for both the young patients and their families. Ever since NexoBrid received its initial approval, our focus has been on broadening its application to children. This demonstrates our unwavering dedication to transforming burn care in the long run.
NexoBrid is one of MediWound's main products, featured prominently on the company's website along with EscharEx and MW005. EscharEx is a treatment for difficult-to-heal wounds that is currently in advanced clinical development. MW005 is a topical, biological drug being developed to address the treatment needs of low-risk basal cell carcinoma cases.
In December 2023, MediWound received an additional $6.7 million funding from the US Department of Defense (DoD). This brings their total research and development budget from the DoD's Medical Technology Enterprise Consortium to $14.4 million. The funding will be used to further develop NexoBrid, a non-surgical solution for burn treatment, specifically designed for field-care use by the US Army.
"The additional funding will improve our CMC activities, speed up preclinical development, and help us set up a GMP-compliant aseptic production line for the temperature-stable formulation of NexoBrid," Gonen said in a press release at the time.
Source: MediWound
