FDA delays approval of Mallinckrodt's StrataGraft

The US Food and Drug Administration has informed Ireland-incorporated specialty pharma firm Mallinckrodt (NYSE: MNK) that 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, said Mallinckrodt, which acquired rights to the product with its acquisition of Stratatech Corp, a privately-held Wisconsin-based regenerative medicine company, in 2016.

At that time, Mallinckrodt said that, if approved, StrataGraft could be the first biological "off-the-shelf" skin substitute product for treatment of severe burns. Mallinckrodt estimated the market size at $300 million based off the treatment of 10,000 patients annually for severe burns in the USA.