Novo Nordisk won't seek clearance for NovoSeven for bleeding in the brain |
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Mon, 26 Feb 2007 08:58
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COPENHAGEN (AFX) - Novo Nordisk AS said it has decided not to apply for regulatory approval for its NovoSeven product to treat intracerebral haemorrhage (ICH), or bleeding in the brain, after mortality and severe disability had not improved after a 90 day study period.Novo Nordisk said its Phase 3 stroke trial showed that its NovoSeven reduced bleeding in the brain, but did not not achieve long term improvement.NovoSeven significantly reduced bleeding in the brain compared to placebo on day 15, but mortality and severe disability had not improved at the 90 day primary endpoint of the study, it said.Novo Nordisk's other R&D in critical bleeding will continue as planned, it said.The company said this decision regarding NovoSeven does not change Novo Nordisk's expectations for the company's financial results for 2007.michael.delaine@thomson.commdl/jfrCOPYRIGHTCopyright 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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Novo Nordisk's NovoSeven has potential for 14 bln dkr sales by 2015 - Citigroup 