Mallinckrodt plc announced Wednesday that the U.S. Food and Drug Administration or FDA has approved StrataGraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat) for the treatment of adult patients with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated.

StrataGraft is developed by Stratatech Corp., a Mallinckrodt company. The FDA granted StrataGraft regenerative medicine advanced therapy (RMAT), Priority Review and Orphan Drug designations for the indication.

Thermal burns are typically caused by direct contact with an external heat source such as steam, scalding water, hot surfaces or fire.

The current standard of care for deep partial-thickness thermal burns is Autograft, which involves the surgical harvesting of healthy skin from an uninjured site on the patient and transplanting the skin graft to the injury, leaving the patient with more wounded areas requiring care.

StrataGraft, an investigational regenerative skin tissue therapy, is now approved for the treatment of adult patients with deep partial-thickness thermal burns. It is an engineered, bilayer tissue and is designed to mimic natural human skin with both inner dermis-like and outer epidermis-like layers.

StrataGraft is the first approved donor site-free alternative to autograft for deep partial-thickness burns designed to handle like an autograft and support body’s own ability to heal. StrataGraft contains metabolically active cells that produce and secrete a variety of growth factors and cytokines. Growth factors and cytokines are known to be involved in wound repair and regeneration.

The approval is based on data from the pivotal Phase 3 STRATA2016 clinical trials of a single application of StrataGraft in patients with acute thermal burns. The data demonstrated autograft sparing and durable wound closure by 3 months in adults with deep partial-thickness burns, providing burn surgeons with a new treatment option to reduce or eliminate autografting.

Each year, approximately 40,000 patients in the United States require hospitalization for the treatment of severe burns. Autograft is the current standard of care for deep partial-thickness burns.

Additionally, Mallinckrodt said it plans to conduct a study evaluating StrataGraft in the treatment of pediatric populations. The safety and effectiveness of StrataGraft in pediatric patients below 18 years have not been established.

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