Roche says arthritis drug Actemra successful in phase III study UPDATE |
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Published
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Tue, 10 Jul 2007 11:34
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(Updating with Roche to seek FDA approval by yr-end)ZURICH (Thomson Financial) - Roche Holdings AG said that arthritis drug Actemra has proved successful in a phase III clinical study evaluating the effectiveness of the drug in patients with difficult-to-treat rheumatoid arthritis (RA).The Radiate study was conducted over 24 weeks with 498 patients with difficult-to-treat RA.'The greater proportion of patients treated with Actemra plus methotrexate, achieved a significant improvement in disease signs and symptoms,' Roche said.A spokesman from the pharmaceuticals group said that Roche plans to file for the drug's approval with the US Food and Drug Administration (FDA) by the end of 2007.The results add to the data being compiled ahead of the anticipated regulatory filing later this year, said Roche.The Radiate study focused on patients with moderate to severe active RA whose joints are significantly more affected by the disease, and who did not respond well to anti-tumour necrosis factor therapy (anti-TNF).sarah.fenwick@thomson.comsf/cm2/sf/jlwCOPYRIGHTCopyright 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's arthritis drug Actemra reaches goal in 2nd phase III study 