Novartis says scope of additional diabetes drug study uncertain |
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Mon, 26 Feb 2007 16:37
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ZURICH (AFX) - Novartis AG said the scope of additional studies on the safety of diabetes drug Galvus for treatment of patients with the type 2 version of the illness is not yet clear.'The US Food and Drug Administration (FDA) has requested additional data...I do not think a 'single dose study' will be sufficient,' Novartis head of pharma development James Shannon said.Shannon said that the Swiss pharma group's talks with the FDA remained at early stages and that therefore the scope and timing of additional studies remained uncertain.Shannon declined to comment on any potential impact a delay might have on Galvus' market position as compared with Merck's competitor drug Januvia, which has already been launched.'I cannot speculate on that,' Shannon said.Earlier, the US regulator requested additional data, including a clinical study to demonstrate the safety of Galvus in patient groups with kidney impairment, leading to a possible further delay approval in US.Novartis said its financial guidance for 2007 remains unchanged,and that it remains committed to gaining regulatory clearance for Galvus.Galvus was submitted for US approval in Jan 2006 as a once-daily oral treatment for type 2 diabetes.afx.zurich@afxnews.comjmt/rfwCOPYRIGHTCopyright 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.AFX News and AFX Financial News Logo are registered trademarks of AFX News Limited
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Novartis 'committed' to Galvus after gets FDA approvable letter 