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

FDA Approves New Use of Transplant Drug Based on Real-World Evidence 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)](/science-research/science-and-research-special-topics/real-world-evidence) of effectiveness.

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. The data were collected on all lung transplants in the U.S. and were supplemented by information from the Social Security Administration’s Death Master File as a trusted repository of mortality data. A dramatic improvement in outcomes was observed among lung transplant patients receiving Prograf as part of their immunosuppression medications compared to the well-documented natural history of a transplanted drug with no or minimal immunosuppressive therapy.  

Read the source article at fda.gov
2021-07-16 01:00:00