Stratatech/Mallinckrodt has completed its rolling submission of its BLA to the FDA for StrataGraft, for the treatment deep partial-thickness thermal burns.

Mallinckrodt Plc announced that Stratatech, a Mallinckrodt company, has completed its rolling submission of a Biologics License Application (BLA) to the FDA for StrataGraft, a regenerative skin tissue therapy in development for the treatment of adult patients with deep partial-thickness thermal burns. The company previously announced initiation of the rolling submission in April. StrataGraft skin tissue is an investigational product, and its safety and effectiveness have not yet been established by the FDA. The StrataGraft skin tissue BLA is based on data from the pivotal Phase III STRATA2016 clinical trial, previously published as an abstract in the Journal Of Burn Care & Research and accepted for presentation at the American Burn Association 52nd Annual Meeting, with support from the STRATA2011 clinical trial, previously published in Burns. The FDA granted StrataGraft skin tissue 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.