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FDA OKs Regimen for Transplant Patients

April 11, 2003

WASHINGTON (AP) _ Some kidney transplant patients could reduce use of one drug that suppresses their immune systems, potentially improving kidney function, the Food and Drug Administration said Friday.

The FDA said patients at low to moderate risk of rejecting the new organ could stop taking the drug cyclosporine two to four months after transplant by substituting higher doses of the drug Rapamune.

Currently, all kidney transplant patients are treated with a combination of drugs to suppress their immune system _ typically three or more _ to prevent organ rejection. Among the approved drug regimens are the combination of cyclosporine and sirolimus, the generic name for Rapamune.

While the combination is necessary to prevent rejection, FDA said, it may carry long-term risks to the functioning of the transplanted kidney.

Dr. Marc Cavaille-Coll of the FDA said that in the combination, cyclosporine was associated with some kidney toxicity and the ability to stop using it earlier helped improve long-term kidney function.

He said a clinical trial found that the benefit continued for 36 months after the transplant.

There were 14,427 kidney transplants in the United States in 2000, according to the U.S. Renal Data System. The FDA said more than half could potentially benefit from this change in drugs.

FDA said it acted following a clinical trial involving 525 patients found that survival of the transplanted organ and the patient was the same in groups that stopped the cyclosporine and in those that used standard therapy.

Rapamune is made by Wyeth Pharmaceuticals Inc. of Philadelphia.


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Food and Drug Administration: http://www/fda/gov

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