The FDA has accepted for review the BLA for StrataGraft, an investigational regenerative skin tissue therapy, in development for the treatment of deep partial-thickness thermal burns.- Mallinckrodt

Mallinckrodt Plc announced that the FDA has accepted for review the Stratatech Biologics License Application (BLA) for StrataGraft, an investigational regenerative skin tissue therapy in development for the treatment of adult patients with deep partial-thickness thermal burns. The FDA granted the application priority review and assigned a Prescription Drug User Fee Act (PDUFA) target date of February 2, 2021.Autograft, the current standard of care for deep partial-thickness thermal burns, 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. Each year, approximately 40,000 patients in the U.S. require hospitalization for the treatment of severe burns. 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), expressed interest in StrataGraft skin tissue as a medical countermeasure in response to large-scale burn incidents, and provided funding and technical support for the continued development of StrataGraft skin tissue.