UCB confirms it will meet with FDA on Cimzia |
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Published
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Fri, 02 Feb 2007 15:45
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BRUSSELS (AFX) - Belgian pharmaceutical group UCB SA confirmed that it will meet with the US Food and Drug Administration to discuss its Crohn's disease drug Cimzia.'UCB is expecting to meet with the FDA later this month or early March to discuss the questions they asked in the context of the application for approval of Cimzia for Crohn's disease in the USA,' a spokesman for the company told AFX News.He added that he did not know when the drug would be approved.In December, UCB said it had received a Complete Response Letter from the US Food and Drug Administration requesting additional information and clarification on data submitted in its Biologics License Application (BLA) for the approval of Cimzia in Crohn's disease.UCB said in December it has received positive results from two phase III studies of its Cimzia treatment for another condition, rheumatoid arthritis, but brokers today said they had heard 'rumours there were problems' in UCB's drugs pipeline.frances.robinson@afxnews.comfr/icCOPYRIGHTCopyright AFX News Limited 2006. 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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