FDA approves Prograf to prevent organ rejection in lung transplant recipients

The FDA has approved the immunosuppressant drug tacrolimus to prevent rejection in adult and pediatric patients who receive lung transplants, according to a press release.

Tacrolimus (Prograf, Astellas Pharma) is the only immunosuppressant drug for this population, according to the release.

Prograf was originally approved to prevent organ rejection in patients receiving liver transplants and was later approved to prevent organ rejection for kidney and heart transplants. The drug has also been routinely used in clinical practice for patients receiving lung transplants, according to the release.

Th new approval was based on an observational study that provided real-world evidence of the effectiveness of tacrolimus to prevent organ rejection in adults and children undergoing lung transplantation. The noninterventional study supporting approval for the new indication used real-world data from the U.S. Scientific Registry of Transplant Recipients, supported by the Department of Health and Human Services. Data were collected on all lung transplants in the U.S. and were supplemented by mortality data from the Social Security Administration’s Death Master File. Researchers observed a dramatic improvement in outcomes among lung transplant recipients who received tacrolimus as part of their immunosuppression medications compared with the well-documented natural history of a transplanted drugs with no or minimal immunosuppressive therapy, according to the release.

In addition, evidence from randomized controlled trials of tacrolimus used in other solid organ transplant settings provided evidence of effectiveness and clinical trial evidence from research publications support tacrolimus as part of a multidrug immunosuppressive regimen, according to the release.