Novartis sees FDA Galvus approval update by end of August, Tasigna by Q4 UPDATE |
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Tue, 17 Jul 2007 14:58
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(Updating to add new resubmission estimate for Galvus)ZURICH (Thomson Financial) - Novartis AG said it expects to get feedback from the US Food and Drug Administration on the approval process for its diabetes drug Galvus by the end of August, and plans to resubmit for approval in 2009.The US regulator had requested additional data on the drug, including a clinical study to demonstrate the safety of Galvus in patient groups with kidney impairment.The FDA is concerned about Galvus causing skin lesions in renally impaired patients, and has requested additional testing of at least several hundred patients, Novartis said in an analyst telephone conference.If Novartis' proposal is accepted by the FDA, it would take until the end of 2008 to complete the testing, and Novartis plans to resubmit Galvus in 50 mg and 100 mg dosages for approval in 2009.The Swiss pharma group also said, in slides accompanying an analyst conference call today, that it now expects the FDA to decide on potential approval for cancer drug Tasigna in the fourth quarter.Earlier, the FDA said it will delay its review period for Tasigna by three months.The FDA wants more time to analyse new data on Tasigna, according to Novartis.johanna.treeck@thomson.comjmt/slj/sf/mas/bsdCOPYRIGHTCopyright 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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Novartis expects FDA Galvus approval update by end of August, Tasigna by Q4 