Sumary of FDA approves Prograf to prevent organ rejection in lung transplant recipients:
- July 22, 2021 1 min read ADD TOPIC TO EMAIL ALERTS Receive an email when new articles are posted on Please provide your email address to receive an email when new articles are posted on .
- Back to Healio 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.
- 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.