Roche to file Actemra for marketing approval by end year |
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Wed, 25 Jul 2007 07:17
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ZURICH (Thomson Financial) - Roche Holdings AG said it plans a regulatory filing for marketing approval of rheumatoid arthritis drug Actemra, after successfully completing a fourth phase III study.The Swiss pharma group said the study, which aimed to demonstrate the safety and efficacy of Actemra monotherapy, successfully met its primary endpoint in patients with moderate to severe rheumatoid arthritis.'This is the first multinational phase III trial using Actemra monotherapy. The trial demonstrates Actemra's safety and efficacy, reinforcing the role of IL-6 receptor inhibition in RA' said William Burns, CEO Pharmaceuticals Division of Roche.The study, together with data from the previous three studies, will form the basis of the regulatory filing for marketing approval later this year, Roche said.johanna.treeck@thomson.comjmt/sljCOPYRIGHTCopyright 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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Roche says arthritis drug Actemra successful in phase III study UPDATE 