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| |  European Union Approves Rapamune (Sirolimus) For Kidney Transplants MADISON, NJ -- March 15, 2001 -- Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corporation (NYSE: AHP) announced that Rapamune® (sirolimus), the first in a distinct class of immunosuppressant agents developed for the prevention of organ rejection following renal transplantation, has received marketing authorization from the European Commission (EC) representing 15 European countries. This approval follows the December 2000 unanimous positive opinion for approval from the Committee for Proprietary Medicinal Products (CPMP), the scientific advisory body of the European Medicines Evaluation Agency (EMEA). The EC recommend that Rapamune be indicated "for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant." As reported in the 16 November 2000 CPMP summary of the opinion published by the EMEA, "The benefits with Rapamune pertain to its ability to provide adequate immunosuppression during maintenance therapy with corticosteroids, without causing nephrotoxicity." The European agency based its evaluation on data from clinical studies with more than 2,500 patients. "Rapamune provides an important treatment option for renal transplant patients," said Joseph S. Camardo, M.D., Senior Vice President, Clinical Research and Development, Wyeth-Ayerst Research. "The data supported the conclusions of the CPMP that Rapamune is an effective alternative for long-term immunosuppression in the target population." Kidney transplantation is the most common type of organ transplantation procedure in Europe, with more than 13,000 transplants occurring in 1997. To help reduce the risk of organ rejection, transplant patients are given a life-long regimen of immunosuppressant agents. These drugs are intended to lower the body's normal immune response, allowing the transplanted organ to remain functional. Rapamune was approved in the United States in September 1999 and has also been approved in Argentina, Canada, Colombia, Curacao, Brazil, Chile, Malta, Mexico, Peru, South Africa, Switzerland, Taiwan, Trinidad, and Venezuela, and registration is pending approval in Russia, as well as several countries in Asia. In the United States Rapamune is indicated for the prophylaxis of organ rejection in patients receiving renal transplants, and it is recommended that Rapamune be used in a regimen with cyclosporine and corticosteroids. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of renal transplant patients should use Rapamune. Increased serum cholesterol and triglycerides that may require treatment occurred more frequently in patients treated with Rapamune compared to azathioprine or placebo controls. Mean serum creatinine was increased and mean glomerular filtration rate was decreased in patients treated with Rapamune and cyclosporine compared to those treated with cyclosporine and placebo or azathioprine controls. Renal function should be monitored during the administration of maintenance immunosuppression regimens including Rapamune in combination with cyclosporine, and appropriate adjustment of the immunosuppression regimen should be considered in patients with elevated serum creatinine levels. Caution should be exercised when using agents which are known to impair renal function. Specific adverse reactions associated with Rapamune administration occurring at a significantly higher frequency vs. controls were for both 2 and 5 mg/day: hypercholesterolemia, hyperlipemia, lymphocele, hypertension, elevated lactate dehydrogenase, and rash; for 5 mg/day: anemia, arthralgia, diarrhea, hypokalemia, and thrombocytopenia; and for 2 mg/day: acne. Elevations of triglycerides and cholesterol, and decreases in platelets and hemoglobin occurred in a dose-related manner. Related Link: Wyeth-Ayerst Laboratories.
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