FDA Approves Pediatric Indication for Non-Surgical Severe Thermal Burn Treatment

MediWound, based in Yavne, Israel, announced in a press release on Aug. 15, 2024 that NexoBrid (anacaulase-bcdb) has been granted a pediatric indication by FDA for treatment of deep partial and/or full-thickness thermal burns (1). FDA’s decision, according to MediWound, was based on the results of a worldwide Phase III clinical trial (Children Innovation Debridement Study, CIDS) funded by the Biomedical Advanced Research and Development Authority, of the Administration for Strategic Preparedness and Response at the United States Department of Health and Human Services, which built in part upon data available from previous Phase III and Phase II studies.

NexoBrid is topically administered, MediWound said, and enzymatically removes nonviable burn tissue—also known as eschar—without harming viable tissue. It has been designated as an orphan biologic drug in more than 40 countries; now, with its approval in the United States for children from newborns to 18 years of age, it is authorized for use on burn patients of all ages in the US, the European Union, and Japan (1).

MediWound specializes in developing, producing, and marketing rapid, effective biologics, specifically next-generation enzymatic therapeutics which are designed to facilitate non-surgical tissue repair (1). The company’s European headquarters are in Rüsselsheim, Germany; its US base is in Wilmington, Delaware (2).

“Today's announcement marks a significant milestone in our mission to improve burn care with NexoBrid,” said Ofer Gonen, MediWound chief executive officer, in the press release. “Pediatric burn victims represent over 30% of the total burn population, and the current surgical standard of care can be extremely traumatic for both patients and their families. Since NexoBrid's initial approval, we have been dedicated to expanding its use to children, reflecting our long-term commitment to revolutionizing burn care.”

NexoBrid is one of MediWound’s flagship products, described in detail on the company’s home page alongside EscharEx, a treatment for chronic and other hard-to-heal wounds, which is in advanced stages of clinical development, and MW005, another topical, biological drug currently in development to address treatment needs for cases of low-risk basal cell carcinoma (2).

In December 2023, MediWound was granted an additional $6.7 million by the US Department of Defense (DoD), bringing its R&D budget from the DoD’s Medical Technology Enterprise Consortium up to $14.4 million total, to develop NexoBrid into a non-surgical solution for field-care burn treatment to be used by the US Army (3).

“The additional funding will enhance our CMC [chemistry, manufacturing, and controls] activities, expedite preclinical development, and facilitate the establishment of a GMP [good manufacturing practice]-compliant aseptic production line for the temperature-stable formulation of NexoBrid," Gonen said in a press release at the time.

References

1. MediWound. MediWound Announces US Food and Drug Administration Approval of NexoBrid for the Treatment of Pediatric Patients with Severe Thermal Burns. Press Release. Aug. 15, 2024.
2. MediWound. Home Page. Mediwound.com (accessed Aug. 19, 2024).
3. Mirasol, F. DoD Grants Additional Funds to MediWound for Advancement of Non-Surgical Treatment for Field Care Burns. PharmTech.com, Jan. 5, 2024 (accessed Aug. 19, 2024).