Prograf capsules and Prograf for injection -- the first products approved in the U.S. for heart transplantation in eight years -- had been previously approved to prevent graft rejection in liver and kidney transplant recipients.
"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," says the FDA's Steven Galson, MD, MPH, in a news release. Galson directs the FDA's 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," Galson says.
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 FDA states.
The safety and effectiveness of Prograf-based and cyclosporine-based immunosuppression in heart transplantation were compared in two trials, one 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 one year after transplantation in the Prograf group (93.5%) was similar to the cyclosporine group (86.1%).
Prograf's use is associated with increased risk or neurotoxicity, renal function impairment, infection, and posttransplant diabetes. Like most combination immunosuppressive regimens used in solid organ transplantation, using Prograf-based combination immunosuppression is associated with an increased risk of malignancies, notably of nonmelanoma skin cancers.
Prograf is manufactured by Astellas Pharma US Inc.