Mallinckrodt announces FDA approval of StrataGraft to treat thermal burns

Mallinckrodt Plc announced that the FDA has approved StrataGraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat) for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns).

This project was funded in part with $86 million from the Biomedical Advanced Research And Development Authority (BARDA), part of the Office Of The Assistant Secretary for Preparedness and Response at the U.S. Department Of Health And Human Services (HHS), under contract HHSO100201500027 for Stratatech Corporation, a Mallinckrodt company, to develop StrataGraft.

The FDA approval is supported by data from the pivotal Phase III STRATA2016 clinical trial of a single application of StrataGraft in patients with acute thermal burns containing intact dermal elements (deep partial-thickness burns) involving 3%-37% total body surface area, which was conducted at U.S. burn centers. Results, which were recently published in Burns, showed a significantly smaller area of burn wounds treated with StrataGraft required autografting by 3 months compared to the area of burn wounds treated exclusively with autograft (p<0.0001).

“While autografting is effective in providing closure of the original wound in patients with deep partial-thickness burns, it can lead to donor site complications, including pain, itching, increased risk of infection and scarring,” said Tracee Short, M.D., Burn Surgeon And Burn Unit Medical Director At The Regional Burn Center At Baton Rouge General. “The approval of StrataGraft represents an important advancement in the treatment of patients with deep partial-thickness burns. Burn surgeons will now have a new biologic treatment to eliminate or reduce the need for autografting.”

See-” A phase III, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft construct in patients with deep partial-thickness thermal burns.”- Angela L.F.Gibson, James H.Holmes IV,et al.,https://doi.org/10.1016/j.burns.2021.04.021.