FDA Approves New Use of Transplant Drug Based on Real-World Evidence

发布时间： 2021-07-29 阅读：397次

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July 16, 2021 -- Today, the U.S. Food and Drug Administration approved a new use for Prograf (tacrolimus) based on a non-interventional (observational) study providing real-world evidence (RWE) of effectiveness. FDA approved Prograf for use in combination with other immunosuppressant drugs to prevent organ rejection in adult and pediatric patients receiving lung transplantation.

Prograf, originally approved to prevent organ rejection in patients receiving liver transplants, was later approved to prevent organ rejection for kidney and heart transplants as well. The drug has also been routinely used in clinical practice for patients receiving lung transplants. Today’s action marks the first approval of an immunosuppressant drug to prevent rejection in adults and pediatric patients who receive lung transplants.

This approval reflects how a well-designed, non-interventional study relying on fit-for-purpose real-world data (RWD), when compared with a suitable control, can be considered adequate and well-controlled under FDA regulations. Specifically, the non-interventional study supporting approval for this new indication used RWD from the U.S. Scientific Registry of Transplant Recipients (SRTR), supported by the Department of Health and Human Services.

In addition to the RWE from the non-interventional study, randomized controlled trials of Prograf used in other solid organ transplant settings provided confirmatory evidence of effectiveness. Additional clinical trial evidence from research publications supports the independent contribution of Prograf as part of a multidrug immunosuppressive regimen.