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The FDA Approves New Sirolimus Labeling, Improves Transplanted Kidney Functioning

ROCKVILLE, MD -- April 11, 2003 -- The Food and Drug Administration (FDA) today announced the approval of revised labeling for Rapamune (sirolimus) that will allow new kidney transplant patients at low to moderate immunologic risk of organ rejection to stop taking cyclosporine 2 to 4 months after transplantation. By substituting higher levels of Rapamune for cyclosporine, it is hoped that kidney function will improve.

Today’s action is the first approval of a cyclosporine-sparing regimen for new kidney transplant patients. Currently, all kidney transplant patients are treated with a combination of medications -- typically three or more immunosuppressant drugs -- to prevent organ rejection.

More than one-half of all new kidney transplant patients could potentially benefit from this newly approved regimen. In the year 2000 alone there were 14,427 kidney transplants in the United States, according to the U.S. Renal Data System, a project of the National Institute of Diabetes & Digestive & Kidney Diseases at the National Institutes of Health.

The combined use of Rapamune and cyclosporine is necessary but may carry long-term risks to the transplanted kidney function. The ability to take kidney transplant patients off cyclosporine 2-4 months after transplantation, without increased risk of organ rejection, is therefore likely to be associated with improved kidney function.

FDA based its decision on the results of a randomized, multi-center controlled clinical trial that enrolled 525 patients. This study assessed the safety and efficacy of Rapamune as a maintenance regimen, comparing patients who were administered Rapamune, cyclosporine and corticosteroids continuously with patients who received the same standardized therapy for the first 3 months after transplantation followed by the withdrawal of cyclosporine. At 12, 24 and 36 months after transplantation, organ and patient survival were similar for both groups.

Clinical research is currently underway to assess the safety and efficacy of cyclosporine withdrawal in new kidney transplant patients at high-risk of organ rejection, as well as kidney transplant patients who have been taking a combination of immunosuppressive medications for more than 4 months. Therefore, cyclosporine withdrawal and concentration controlled Rapamune use is not being recommended at this time in these additional patient populations.

Wyeth Pharmaceuticals Inc., of Philadelphia, Pa., is the sponsor of the approved New Drug Application (NDA) for Rapamune.

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Decision supported by data from more than 4,000 patients