FDA OKs drug for heart transplant patients

WASHINGTON (Reuters) – U.S. health regulators on Thursday
approved 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.
But the U.S. Food and Drug Administration said the wider
approval would help the more than 2,000 patients who get new
hearts each year.

“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,” said Dr. Steven Galson,
head of the FDA’s Center for Drug Evaluation and Research.

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.

Side effects of Prograf treatment included an increased
risk of kidney impairment, infection and diabetes, the FDA
said. Use of all immune-suppressing transplant drugs also can
increase the risk of cancer when they are used in combination.

Prograf’s main chemical ingredient, tacrolimus, is also
used in the Japanese company’s eczema cream Protopic.