Mallinckrodt's Regenerative Burn Therapy Gets FDA Nod

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Shares of Mallinckrodt plc are up nearly 5% in premarket trading following a late Tuesday announcement that the U.S. Food and Drug Administration (FDA) greenlit the company's severe burn treatment, StrataGraft.

Mallinckrodt's StrataGraft is a product designed to help heal patients who have received thermal burns that would ultimately require a skin graft. It is designed to deliver metabolically active cells that produce different growth factors and cytokines, which are known to support the body's own ability to heal. 

StrataGraft is a bioengineered, allogeneic, "cellularized scaffold product" developed from keratinocytes grown on gelled collagen that contain dermal fibroblasts. A patient's own cells replace StrataGraft over time, the company said. 

StrataGraft was among the first products designated by the FDA as a Regenerative Medicine Advanced Therapy (RMAT) under the provisions of the 21st Century Cures Act. It had also been granted Orphan Drug designation from the FDA. 

In its announcement, Mallinckrodt said the product is the first approved donor site-free alternative to autograft, which is when tissue from one part of the body is transplanted to another. Autograft is the current standard of care for deep partial-thickness burns. It provides burn surgeons with a new treatment option that can eliminate or reduce the need for autografting to "attain definitive closure of the majority of deep partial-thickness treated wounds." 

It is estimated that about 40,000 people in the United States require hospitalization for the treatment of severe burns each year.

Mallinckrodt Chief Scientific Officer Steven Romano said the approval of StrataGraft is a significant milestone for the burn care community. Romano thanked the patients who participated in its clinical development program.

StrataGraft was approved based on data from the Phase III STRATA2016 study that showed 96% of burn patients who used StrataGraft did not require additional autografting. The patients involved in the clinical study had deep thermal burns that covered between 3% and 37% of the total body surface area. Additionally, 83% of patients achieved durable wound closure at the StrataGraft-treatment site without autograft replacement. Trial data showed that StrataGraft achieved durable wound closure by three months in adults with deep partial-thickness burns. The difference in the percent area of StrataGraft compared to the control autograft treatment sites that required autografting by three months in the study was 98%, Mallinckrodt said. 

There were no reports of rejection to StrataGraft in the clinical studies, and no patients discontinued study participation due to adverse reactions. The most common adverse reactions were itching, blisters, hypertrophic scar and impaired healing. 

The development of StrataGraft was funded in part by an $86 million grant from the Biomedical Advanced Research and Development Authority (BARDA). Gary Disbrow, director of BARDA, said multiple security threats could result in severe burn wounds. Healthcare providers need new products to treat these patients that are safe and easy to use. 

"Having new products available on the commercial market to improve routine care for burn patients gives healthcare providers a level of familiarity and comfort in using the products. This improves our healthcare response during a national emergency and reduces the long-term cost of national preparedness," Disbrow said in a statement.

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