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Home Industry News Biogen Idec and Elan report negative CHMP opinion for natalizumab

Biogen Idec and Elan report negative CHMP opinion for natalizumab

19th November 2007

Biogen Idec and Elan have announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a negative opinion for their application for marketing authorisation for natalizumab as a treatment for Crohn’s disease.

This opinion was given following an appeal filed by both companies after the scientific committee published a negative opinion regarding the compound for this indication earlier in the year.

Biogen Idec and Elan report that Tysabri (natalizumab) is currently approved as a treatment for relapsing-remitting multiple sclerosis in the European Union (EU), with clinical trials showing administration of the compound resulting in a 68 per per cent relative reduction in annualised relapse rate.

“This negative opinion is now referred to the European Commission (EC), which grants marketing authorisations in the EU,” the companies report.

The final decision from the EC will follow this recommendation by the CHMP, with both companies expecting to be informed by the commission at some point during the first quarter of 2008.

In October 2007, Elan and Biogen Idec presented new data on the utilisation and safety of Tysabri worldwide at the congress of the European Committee for Treatment and Research in Multiple Sclerosis in Prague.

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