Monoclonal Antibodies
Elan and Biogen Idec Preparing to Appeal Ruling on European Application for Natalizumab for the Treatment of Crohn's Disease
Published in Food and Drug Law Weekly, August 3rd, 2007
Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) announced that they have been informed by the European Medicines Agency (EMEA) that the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the marketing application for the use of natalizumab in patients with Crohn's disease. In accordance with European regulations, Elan and Biogen Idec plan to apply for a re-examination of the negative opinion through the appeal procedure. A decision on the appeal is expected by 1Q 2008.
"Without natalizumab, European patients with severely active disease who failed other therapies and who are suffering from continuous symptoms may be...
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