US FDA approves tacrolimus for lung transplants

US FDA approves tacrolimus for lung transplants

The US Food and Drug Administration (FDA) has approved the use of the transplant drug tacrolimus (Prograf) for the prevention of organ rejection in adult and pediatric patients receiving lung transplants. This is the only immunosuppressant drug approved for this patient population.

Tacrolimus has been routinely prescribed to lung transplant patients for the past 15 to 20 years and is “the primary calcineurin inhibitor used as the backbone of immunosuppression for lung transplants,” told Joshua Diamond, MD, associate medical director of the Penn Lung Transplant Program at Penn Medicine, in Philadelphia, Pennsylvania, in a statement.

The FDA originally approved tacrolimus in 1994 for the prevention of rejection in patients receiving liver transplants. The approval was expanded for use in preventing rejection in kidney and heart transplant recipients. This newest approval comes after an observational study using lung transplant data from the Scientific Registry of Transplant Recipients and mortality information from the Social Security Administration.

“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,” the FDA said in the announcement. The organization also noted that clinical trials of the drug involving other solid organs further bolstered evidence of its effectiveness.

Joshua Diamond does not anticipate that this new approval will affect clinical practice, but it could help transplant recipients more easily obtain insurance coverage for the immunosuppressant drug.