Novartis' Rasilez, other hypertension drugs gain positive opinion from EU body |
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Fri, 22 Jun 2007 14:01
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ZURICH (Thomson Financial) - Novartis AG said it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending European Union approval of Rasilez as the first new type of high blood pressure treatment in more than a decade.The EU commission generally follows the CHMP's recommendations and is expected to issue a decision within three months.The Committee issued the positive opinion for Rasilez based on data from more than 7,800 patients in 44 clinical studies, which showed that Rasilez provided significant blood pressure reductions for 24 hours and beyond, the Swiss pharmaceutical group said.Other higher blood pressure drugs, including Tekturna, Enviage, Sprimeo, and Riprazo also received positive reviews.In a separate review, the committee also said it is recommending marketing authorisation for Novartis unit Sandoz' anaemia treatment Bioncrit in a pre-filled syringe.The drug is being recommended for use in anaemia associated with chronic kidney disease and in oncology patients, CHMP said.Moreover, the European body is recommending use of the drug to reduce blood transfusion requirements in oncology patients and prior to elective orthopaedic surgery.Studies have shown Binocrit to have a comparable quality, safety and efficacy profile to Erypo/Eprex, CHMP said.johanna.treeck@thomson.comjmt/jsa/jmt/ejbCOPYRIGHTCopyright AFX News Limited 2007. All rights reserved.The copying, republication or redistribution of AFX News Content, including by framing or similar means, is expressly prohibited without the prior written consent of AFX News.
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