UCB to launch clinical study for Cimzia to to meet FDA demands |
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Published
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Fri, 23 Mar 2007 08:20
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BRUSSELS (AFX) - Belgian pharmaceutical group UCB SA said it will launch a short-term clinical study of its Crohn's disease drug, Cimzia, to provide additional clinical efficacy data to the US Food and Drug Administration (FDA).UCB expects to see results from the study in the second half of 2008.The group said it will are ply fully' by the end of April to the Complete Response Letter it received from the FDA in December last year.The letter requested additional information and clarification on data submitted in its Biologics License Application (BLA) for the approval of Cimzia in the treatment of Crohn's disease.UCB also plans to file a BLA with the FDA for Cimzia in the treatment of rheumatoid arthritis by the end of this year.nina.chestney@thomson.comnc/ms1COPYRIGHTCopyright 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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UCB says Cimzia shows 'significant' results in preventing damage to joints 