Astellas Announces FDA Approval of Prograf (Tacrolimus) for Lung Transplant Rejection Prophylaxis Based on Real-World Evidence

Recently, the U.S. FDA announced that, based on real-world evidence (RWE) reflecting efficacy provided by a non-interventional study, it approved Astellas’s Prograf (tacrolimus) for use in combination with other immunosuppressive drugs to prevent organ rejection in adult and pediatric patients undergoing lung transplantation.

Prograf was initially approved for the prevention of organ rejection in patients receiving liver transplants and was later approved for the prevention of organ rejection in kidney and heart transplant recipients. The drug is also routinely used in clinical practice for patients undergoing lung transplantation. The FDA press release stated that this approval marks the first time an immunosuppressive drug has been approved for the prevention of rejection in adult and pediatric patients receiving lung transplants.

This approval demonstrates that well-designed non-interventional studies, relying on appropriate real-world data (RWD) and compared with suitable controls, can be considered by the FDA to provide adequate and well-controlled comparisons. Specifically, the non-interventional study supporting the approval of this new indication utilized RWD from the Scientific Registry of Transplant Recipients (SRTR) in the United States and was supported by the Department of Health and Human Services.

It collects data on all lung transplants in the United States, supplemented by reliable mortality data from the Social Security Administration. Compared with transplant recipients receiving no or very limited immunosuppressive therapy, a significant improvement in outcomes was observed in lung transplant patients who received Prograf as part of their immunosuppressive regimen.

In addition to the real-world evidence (RWE) provided by non-interventional studies, randomized controlled clinical trials evaluating the use of Prograf in other solid organ transplant settings have provided confirmatory evidence of efficacy. Other published clinical trial evidence supports the independent contribution of Prograf as a component of a multi-drug immunosuppressive regimen.

References:

[1] FDA Approves New Use of Transplant Drug Based on Real-World Evidence. Retrieved July 16, 2021, from https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-new-use-transplant-drug-based-real-world-evidence

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