Biologics license application for StrataGraft completed

Stratatech has completed rolling submission of a biologics license application to the FDA for StrataGraft, according to a press release.

StrataGraft is an investigational regenerative skin tissue therapy developed for the treatment of deep partial-thickness thermal burns.

“Completion of the BLA submission is the culmination of many years of hard work and brings us one step closer to our goal of providing StrataGraft skin tissue as a new treatment option for patients in the United States with deep partial-thickness thermal burns, if approved,” Steven Romano, MD, executive vice president and chief scientific officer at Mallinckrodt, Stratatech’s parent company, said in the release. “We look forward to working closely with the FDA during the regulatory review process.”

StrataGraft previously received orphan drug status from the FDA and has been designated as a regenerative medicine advanced therapy.