FDA approves StrataGraft for thermal burns

StrataGraft, a bioengineered bilayer construct designed to mimic human skin, has been approved by the FDA for the treatment of thermal burns in which intact dermal elements remain and surgical intervention is indicated.

Produced from two types of human skin cells, keratinocytes and dermal fibroblasts, StrataGraft is for topical application on burned skin. The patient’s skin cells should then grow to replace the lost skin, and the treatment can decrease the amount of healthy skin needed for grafting.

“Today’s FDA approval of StrataGraft marks a significant milestone for the burn care community and underscores our unwavering commitment and ability to bring paradigm-changing treatment options to patients with severe and critical conditions,” Steven Romano, MD, executive vice president and chief scientific officer at Mallinckrodt, said in a company press release.

The approval was based on data from the phase 3 STRATA2016 clinical trial in which deep partial-thickness burns involving 3% to 37% of total body surface area treated with StrataGraft required a significantly smaller area requiring autografting by 3 months compared with those treated exclusively with autograft.

“Serious burns can be an incredibly difficult injury to treat and can adversely affect more than just the skin. 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,” Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, said in a separate release from the agency. “This approval provides health care professionals a novel way to treat burn wounds.”