sirolimus [`rapamune'; wyeth-ayerst] has received a positive opinion for approval in the eu

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Inpharma 1268 - 16 Dec 2000 Sirolimus [‘Rapamune’; Wyeth-Ayerst] has received a positive opinion for approval in the EU (European Union) for use in the prevention of renal transplant rejection from the European Medicines Evaluation Agency’s Committee for Proprietary Medicinal Products (CPMP). Specifically, the CPMP recommended that sirolimus be approved for the prevention of organ rejection in patients undergoing renal transplantation who are at low-to-moderate immunological risk. In addition, the CPMP made a recommendation that sirolimus be used in combination with modified cyclosporin and corticosteroids initially (for 2–3 months), then as maintenance therapy in combination with corticosteroids if modified cyclosporin can be progressively discontinued. Wyeth-Ayerst Pharmaceuticals. Rapamune receives unanimous positive opinion from the European Medicines Evaluation Agency (EMEA). Media Release : [3 pages], 11 Dec 2000. Available from: URL: http://www.ahp.com/ wyeth.htm 800852139 1 Inpharma 16 Dec 2000 No. 1268 1173-8324/10/1268-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Inpharma 1268 - 16 Dec 2000

■ Sirolimus [‘Rapamune’; Wyeth-Ayerst] hasreceived a positive opinion for approval in the EU(European Union) for use in the prevention of renaltransplant rejection from the European MedicinesEvaluation Agency’s Committee for ProprietaryMedicinal Products (CPMP). Specifically, the CPMPrecommended that sirolimus be approved for theprevention of organ rejection in patients undergoingrenal transplantation who are at low-to-moderateimmunological risk. In addition, the CPMP made arecommendation that sirolimus be used incombination with modified cyclosporin andcorticosteroids initially (for 2–3 months), then asmaintenance therapy in combination withcorticosteroids if modified cyclosporin can beprogressively discontinued.Wyeth-Ayerst Pharmaceuticals. Rapamune receives unanimous positiveopinion from the European Medicines Evaluation Agency (EMEA). MediaRelease : [3 pages], 11 Dec 2000. Available from: URL: http://www.ahp.com/wyeth.htm 800852139

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Inpharma 16 Dec 2000 No. 12681173-8324/10/1268-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved