US FDA approves new Prograf use, supported by real-world evidence

The US FDA has announced its approval of tacrolimus (brand name Prograf) for use in combination with other immunosuppressant drugs to help prevent organ rejection in adult and pediatric populations receiving lung transplants. The approval is significant as it was supported by real-world evidence from an observational study of the effectiveness of the drug for the new use. Prograf is an immunosuppressive drug, originally approved to help prevent organ rejection in individuals undergoing liver transplants. The drug was subsequently approved for use in cases of kidney and heart transplants. Prograf has also been routinely used as part of antirejection therapy...