FDA approves immunosuppressive agents based on real-world data to expand the scope of application

A few days ago, the US FDA announced that it has approved Astellas's Procofol (tacrolimus) based on real-world evidence (RWE) provided by a non-interventional study that reflects the efficacy.

PuleCoff was initially approved to prevent organ rejection in patients undergoing liver transplantation, and was later approved to prevent organ rejection in kidney and heart transplants

This approval shows that non-interventional studies carefully designed based on suitable real-world data (RWD) and compared with appropriate controls can be considered by the FDA to provide adequate and good comparisons

It collects data on all lung transplants in the United States, supplemented by reliable information from the Social Security Administration on mortality data

In addition to the RWE provided by non-interventional studies, randomized controlled clinical trials using Puracor in other solid organ transplant settings have provided confirming evidence of effectiveness

Reference materials:

[1] FDA Approves New Use of Transplant Drug Based on Real-World Evidence.