Mallinckrodt StrataGraft Skin Therapy Could Be The First RMAT-Designated Therapy Approved By US FDA

The company presented positive data from a Phase III pivotal trial during the American Burn Association virtual annual meeting.

Regenerative Agriculture, Holistic Management, farming problem concept. Yellow field with a blue sky and a green forest with grass.
Stratagraft is designed to regrow living tissue

Mallinckrodt PLC's StrataGraft – a regenerative skin tissue therapy – appears closer to reaching the market after a long development road. The company announced on 9 June that it completed a rolling Biologics License Application for StrataGraft with the US Food and Drug Administration for the treatment of adult patients with deep partial-thickness (DPT) burns.

The pivotal Phase III trial supporting the submission was also presented at the virtual American Burn Association (ABA) annual meeting on 15 June and was selected as one of the "top five abstracts" by blinded reviewers

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