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Rapamune cyclosporine-sparing regimen approved

Executive Summary

New regimen for Wyeth's Rapamune (sirolimus) will allow patients at low to moderate immunologic risk to stop taking cyclosporine two to four months after kidney transplantation and receive higher doses of Rapamune. Clinical research to assess the safety and efficacy of cyclosporine withdrawal in high-risk patients and patients who have been taking a combination of immunosuppressive medications for more than four months is underway, an April 11 1FDA "Talk Paper" states. An FDA advisory committee voted five to four that the Rapamune cyclosporine-sparing data were not sufficient for approval (2"The Pink Sheet" Jan. 28, 2002, p. 11)...

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