The U.S. Food and Drug Administration (FDA) has informed Mallinckrodt it is deferring action (pending a site inspection) on the Stratatech Biologics License Application (BLA) for StrataGraft®, an investigational allogeneic cellularized scaffold product in development for the treatment of adult patients with deep partial-thickness burns. This is due to COVID-19-related travel restrictions, which are delaying a required manufacturing site inspection.
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), has provided funding and technical support for the continued development of StrataGraft under Project BioShield Contract No. HHSO100201500027C.
"We are confident in the efficacy and safety of StrataGraft for the treatment of deep partial-thickness burns based on our pivotal Phase 3 clinical trial results," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "We plan to work closely with the FDA to complete the review and schedule its site inspection. We remain committed to the burn care community, with a goal of ultimately providing this patient population with a new treatment option that could reduce the need for autografting of healthy skin."
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The FDA granted the BLA for StrataGraft priority review. Previously, the FDA granted StrataGraft orphan drug status, and it was among the first products designated by the agency as a Regenerative Medicine Advanced Therapy (RMAT) under the provisions of the 21st Century Cures Act.
StrataGraft is an investigational treatment being developed to reduce autograft in patients with severe thermal burns. An engineered, bilayer construct, StrataGraft is designed to mimic natural human skin with both inner dermis-like and outer epidermis-like layers. StrataGraft can be sutured, stapled or secured with an adhesive. StrataGraft is cryopreserved in order to deliver viable cells upon application.