FDA Accepts BLA for NexoBrid to Treat Severe Burns

The US Food and Drug Administration (FDA) has accepted MediWound’s re-submitted Biologics License Application (BLA) for NexoBrid, a concentrate of proteolytic enzymes in bromelain¹. MediWound specializes in the development of biotherapeutics solutions for tissue repair and regeneration. NexoBrid is designed for nonsurgical eschar (dead tissue) removal in adults with deep partial-thickness and/or full-thickness thermal burns. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of January 1, 2023.

The re-submitted BLA adds to the already extensive amount of data submitted, including manufacturing data, preclinical and clinical study data, and labeling information. Most importantly, the BLA contains data from the pivotal US Phase 3 study (DETECT) of NexoBrid in adult patients with deep partial and/or full-thickness thermal burns up to 30% of the patient’s total body surface area. The Phase 3 DETECT study met all of its primary and secondary endpoints, including the significantly higher incidence of complete eschar removal with NexoBrid compared to the patients treated with a gel vehicle.

NexoBrid is a topically applied biologic that enzymatically removes dead skin due to severe burns. Removing dead tissue after a severe burn is the most important step in the healing process. The current standard of care utilizes a surgical approach to remove the dead tissue. Surgical excision is traumatic for the patient and can result in the loss of blood or healthy tissue. Other nonsurgical approaches are minimally effective and take too long to work.

One of the primary goals of NexoBrid is to remove the risks associated with surgical debridement, such as infection, sepsis, wound deterioration, and scarring. It also helps to efficiently remove eschar from the wound so physicians can accurately assess the depth and severity of the burn. By eliminating the risks associated with surgical methods, NexoBrid reduces the need for skin grafts and the sacrifice of healthy tissue located from other sites on the patient’s body.

According to MediWound, “NexoBrid was classified by BARDA as a medical countermeasure for thermal and chemical burns address the public health preparedness gap especially for eschar removal needs of a large number of patients in the event of burn mass casualty incident.”²

Disclosure:

NexoBrid development has been supported in part with federal funding from US Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response (ASPR), within the US Department of Health and Human Services (HHS), under ongoing USG Contract numbers HHSO100201500035C and HHSO100201800023C.

References:

1. Mediwound announces US FDA acceptance of biologics license application for NexoBrid for the treatment of severe thermal burns. GlobeNewswire News Room. Published August 3, 2022. Accessed August 18, 2022. https://www.globenewswire.com/news-release/2022/08/03/2491251/30505/en/MediWound-Announces-U-S-FDA-Acceptance-of-Biologics-License-Application-for-NexoBrid-for-the-Treatment-of-Severe-Thermal-Burns.html
2. NexoBrid. Mediwound. Accessed August 18, 2022. https://www.mediwound.com/products/nexobrid/