 |
 |
 |
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | FDA Centennial
|
FOR IMMEDIATE RELEASE |
Media
Inquiries: |
The Food and Drug Administration (FDA,) approved Prograf (tacrolimus), a drug that suppresses the body's immune reaction, for the prevention of graft rejection in the recipients of heart transplants. Prograf capsules and Prograf for injection, the first products approved in the United States for heart transplantation in eight years, had been previously approved for the prevention of graft rejection in the recipients of liver and kidney transplants.
"This approval is another example of the benefits of our agency's 'orphan' drugs program, which seeks to answer the medical needs of small groups of patients," said Dr. Steven Galson, Director for the Center for Drug Evaluation and Research. "The doctors who perform approximately 2,200 heart transplants in the U.S. each year will now have a new option for enhancing successful outcomes by preventing the rejection of the grafted organs."
Prograf acts by a mechanism similar to cyclosporine, another immunosuppressant used to prevent transplant rejection. Thus Prograf offers an alternative to cyclosporine for use in certain combination immunosuppressive regimens in liver, kidney and heart transplantation.
The safety and effectiveness of Prograf-based and cyclosporine-based immunosuppression in heart transplantation were compared in two trials, one of which was conducted in Europe and one in the U.S. In the European trial, the survival of patients and grafts 18 months after the transplantation in the Prograf group (91.7%) was similar to the cyclosporine group (89.8%). In a U.S. study, patient and graft survival at 12 months after transplantation in the Prograf group (93.5%) was similar to the cyclosporine group (86.1%).
The use of Prograf is associated with increased risk or neurotoxicity, renal function impairment, infection, and post-transplant diabetes mellitus. Like most combination immunosuppressive regimens used in solid organ transplantation, the use of Prograf-based combination immunosuppression is associated with an increased risk of malignancies, notably of non-melanoma skin cancers.
Prograf is manufactured by Astellas Pharma US, Inc. in Deerfield, Illinois.
####
RSS Feed for FDA News Releases [what's this?]
Get
free weekly updates about FDA press releases, recalls, speeches, testimony
and more.