FDA Approves Tacrolimus for Lung Transplants

Lucy Hicks

July 19, 2021

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 recipients for the past 15 to 20 years and is "the primary calcineurin inhibitor used as the backbone of immunosuppression for lung transplants," Joshua Diamond, MD, associate medical director of the Penn Lung Transplant Program at Penn Medicine, in Philadelphia, Pennsylvania, told Medscape Medical News in an interview.

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, announced July 16, 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.

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. "Up until now, no drug has been approved," Diamond told Medscape Medical News. Tacrolimus has been prescribed off label to lung transplant recipients. Diamond noted that his patients have not had trouble with coverage for tacrolimus recently, although insurance companies have declined to cover other immunosuppressant medications after transplants. This approval could have a "domino effect for other immune suppressive medications," he said, "such that we don't have to argue with insurance companies for coverage of these medications."

For more news, follow Medscape on Facebook, Twitter, Instagram, and YouTube.


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.