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Grand FDA nod and approval for drug for heart transplant patients

by Medindia Content Team on March 31, 2006 at 7:35 PM
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Grand FDA nod and approval for drug for heart transplant patients

In a relief FDA, the U.S. health regulators, gave their nod to the first new drug in nearly a decade to prevent organ rejection in heart transplant patients.

The drug, Astellas Pharma Inc.'s Prograf, is already cleared to prevent rejection of liver and kidney transplants.

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Dr. Steven Galson, head of the FDA's Center for Drug Evaluation and Research said, "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. Prograf works by suppressing the body's immune system, which can attack new organs it senses as foreign objects."

In one study of U.S. patients, 93.5 percent of patients and their new hearts survived one year after transplant. That rate was similar to what was seen in patients given an older drug, cyclosporine.

Prograf's main chemical ingredient, tacrolimus, is also used in the Japanese company's eczema cream Protopic. so now the drug can have a wider application area and used effectively.

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