FDAnews Drug Daily Bulletin

PROGRAF APPROVED TO PREVENT HEART TRANSPLANT REJECTION

April 11, 2006
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The FDA has approved Astellas Pharma's Prograf -- a drug that suppresses the body's immune response -- for the prevention of graft rejection in heart transplant recipients.

Prograf (tacrolimus) capsules and Prograf for injection had previously been approved for the prevention of graft rejection in recipients of liver and kidney transplants. Prograf is the first product approved in the U.S. for a heart transplant indication in eight years, the FDA said recently.

"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 Steven Galson, director of 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."