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Home Industry News Elan and Biogen Idec to appeal CHMP natalizumab opinion

Elan and Biogen Idec to appeal CHMP natalizumab opinion

20th July 2007

Following the granting of a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) for natalizumab as a treatment for Crohn’s diseases, Elan and Biogen Idec have announced that they are to apply for re-examination of this decision through the official appeals process.

The firms report that the decision on this appeal is expected to be received by the first quarter of 2008.

In December 2006, the companies submitted an application for Tysabri (natalizumab) as a treatment for moderate-to-severe Crohn’s disease with the US Food and Drug Administration, with the body to discuss the application by committee on July 31st 2007.

At present, Tysabri is approved in the EU for relapsing-remitting multiple sclerosis and in the US for relapsing forms of the condition.

Professor Jean-Frederick Colombel at the University of Lille, said: “Without natalizumab, European patients with severely active disease who failed other therapies and who are suffering from continuous symptoms may be offered surgery, with its potential complications.”

He added that, depending on the patients’ condition, they may also be offered clinical trials with unproven and investigational drug candidates or intravenous nutritional therapies.

Earlier this month, Elan welcomed the decision by the National Institute for Health and Clinical Excellence in the UK to recommend the use of Tysabri in patients with highly-active relapsing-remitting multiple sclerosis.

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