FDA nod for new use of transplant drug Prograf

The US Food and Drug Administration on Friday approved a new use for Prograf (tacrolimus) based on a non-interventional (observational) study providing  real-world evidence (RWE) of effectiveness.

The FDA approved Prograf, which is marketed by Japanese drug major Astellas Pharma (TYO: 4503), 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.