Mallinckrodt has received the US Food and Drug Administration (FDA) approval for StrataGraft to treat thermal burns with intact dermal elements in adults.
The approval is for cases where surgical intervention is a clinical indication, also known as deep partial thickness burns.
StrataGraft is made of allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen. It is developed to provide viable cells and aid the body’s healing ability.
The bioengineered, topical, site-free product consists of metabolically active cells that can generate and secrete various growth factors and cytokines, which are associated with wound repair and regeneration.
StrataGraft previously received the FDA orphan drug, regenerative medicine advanced therapy (RMAT) and priority review designations.
It was created in alliance with the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority.
For treatment of many deep burns, the damaged, burned skin is removed and replaced with the patient’s healthy skin from their body.
Use of StrataGraft could avoid or reduce the amount of patient’s healthy skin taken for replacement or grafting, FDA noted.
FDA Center for Biologics Evaluation and Research director Peter Marks said: “The goal of burn management is to help the patient return to the highest level of functionality and independence possible, while improving the overall quality of life.
“This approval provides health care professionals a novel way to treat burn wounds.”
The FDA approval comes after a review of StrataGraft’s effectiveness and safety data from two randomised clinical trials conducted in a total of 101 adults with deep partial thickness thermal burns.
In both trials, a single topical application of StrataGraft or autograft was given after identifying two deep partial-thickness burn wounds having similar area and depth in each patient.
StrataGraft’s effectiveness was determined as the percentage of treatment sites with complete wound closure. It was also demonstrated as the significant reduction in the need for autografts at the StrataGraft treatment sites.
The common side effects related to StrataGraft in clinical trials were itching, blisters, hypertrophic scar and impaired healing at the treatment site.
Overall, the safety profile of the product concerning wound related-events, including redness, swelling, local warmth and wound site infections, was comparable to that of autograft in these trials.
No cases of StrataGraft rejection were reported in the trials and no participants discontinued due to adverse reactions.