MediWound’s NexoBrid is FDA Approved for the Treatment of Severe Thermal Burns

MediWound, a biopharmaceutical company focused on biotherapeutic solutions for tissue repair and regeneration, announced that the US Food and Drug Administration (FDA) approved their orphan biological product NexoBrid (anacaulase-bcdb) for the removal of eschar in adults with deep partial-thickness and/or full-thickness thermal burns.

NexoBrid was already approved for use in 43 countries, including the European Union, India, Japan and others.

Eschar is dead tissue that is cast off from the skin’s surface, particularly after a burn injury.

NexoBrid is an enzymatic debriding drug derived from bromelain, a group of enzymes found in pineapples. This bromelain-based biological product has a mixture of proteolytic enzymes that selectively remove burn eschar without damaging the surrounding viable tissue.

This way, NexoBrid is a non-surgical option to remove eschar from deep-partial and full-thickness thermal burns. Removing eschar in a timely manner is important for lowering the incidence of complications related to burn eschar, such as infection, inflammation and scarring.

“We are pleased and excited that the FDA has approved NexoBrid, an innovative, non-surgical alternative for the treatment of severe burn injuries,” said Ofer Gonen, chief executive officer of MediWound, in the company’s press release. “We appreciate and thank the burn patients who participated in our trials, the clinical investigators and our researchers for their commitment and efforts to attain this significant achievement.”

“We also thank our partner, BARDA [US Biomedical Advanced Research and Development Authority], for their unwavering support since 2015, and our commercial partner, Vericel, who will launch NexoBrid in the US. This US FDA approval of NexoBrid validates our enzymatic technology platform. MediWound will continue to pursue its strategic plans to advance the development of novel therapies for burn care, wound care and tissue repair; we look forward to an exciting and productive 2023,” added Gonen.

Vericel Corporation has an exclusive licence for commercial rights to NexoBrid in North America, and MediWound will get a $7.5 million milestone payment from Vericel due to the recent FDA approval of NexoBrid.

NexoBrid can be applied on the skin in up to two applications, with each application lasting four hours. The first application of NexoBrid can be done up to a 15 percent body surface area. The second application may be applied 24 hours later, as long as the total treated area for both applications together is up to 20 percent total body surface area (TBSA).

“NexoBrid enables fast and effective topical treatment for eschar removal in patients with second- and third-degree thermal burns. I believe that NexoBrid could offer a paradigm shift in burn care and has the potential to become a standard of care in this significant market,” said Lucy A. Wibbenmeyer, MD, clinical professor of Surgery-Acute Care Surgery, Iowa City, IA, and past president of the American Burn Association, in MediWound’s press release.

Clinical Trials of NexoBrid

There were multiple preclinical studies and eight clinical studies that were included in MediWound’s Biologics License Application (BLA) for NexoBrid.

These included the pivotal Phase III US clinical study DETECT that evaluated the safety and efficacy of NexoBrid in 175 adult patients with deep partial-thickness and full-thickness thermal burns of three to 30 percent of TBSA. This study compared NexoBrid to gel vehicle placebo or standard of care (SOC).

The DETECT study met its primary endpoint as the incidence of ≥95 percent eschar removal at the end of the topical treatment period was higher for patients in the NexoBrid group than those in the gel vehicle group.

All secondary endpoints were also met, as NexoBrid was associated with a lower incidence of surgical eschar removal and a shorter time to eschar removal compared to the gel vehicle group. NexoBrid application also resulted in lower blood loss compared to surgical and non-surgical SOC.

The study achieved a safety endpoint of non-inferiority in time to more than 95 percent wound closure in the NexoBrid group compared to the SOC group. Non-inferiority was also determined between NexoBrid and SOC in cosmesis (the preservation or restoration of physical appearance) and function of burn scars after a follow-up time of 12 and 24 months.

The effectiveness and safety of NexoBrid was not established for the treatment of the following: chemical or electrical burns; burns on the face, perineum or genitalia; circumferential burns; burns in individuals with significant cardiopulmonary disease, including inhalation injury; burns on the feet of patients with diabetes mellitus or on the feet of patients with occlusive vascular disease.

In addition, NexoBrid is not recommended for wounds contaminated with hazardous substances to avoid a greater risk of spreading the dangerous substance and any unpredictable reactions with the drug product.