The tissue-based therapy is among the first products to be granted the designation. The 21st Century Cures Act, which was passed in 2016, enabled the FDA to give accelerated review approval to products that meet RMAT criteria.
To win RMAT status, the product must be a cell therapy, therapeutic tissue engineering product, human cell and tissue product or a combination product that uses such therapies. Additionally, the drug needs to be designed for a serious or life-threatening disease and preliminary clinical results must indicate that it has potential to address unmet medical needs for that disease, according to the FDA.
Mallinckrodt’s StrataGraft is a tissue-based therapy in late-stage trials that is designed to promote autologous skin regeneration in patients with deep partial thickness burns.
“We are very pleased the FDA has determined StrataGraft meets the criteria for RMAT designation, as this offers the possibility of priority review and/or accelerated approval,” chief scientific officer & executive VP Dr. Steven Romano said in prepared remarks. “This provides the potential to bring a much-needed therapeutic option to patients even sooner than originally planned.”
RMAT status allows Mallinckrodt to interact earlier and more frequently with the FDA compared to traditional approval pathways.
“RMAT designation of StrataGraft skin tissue speaks to the strength of the clinical data generated during the prior clinical study,” senior VP of regenerative medicine at Mallinckrodt, Lynn-Allen Hoffman, added. “Mallinckrodt is committed to developing advanced regenerative medicine therapies such as StrataGraft for patients with serious conditions.”