Biogen Idec receives CHMP backing for Tysabri label update

Biogen Idec has been granted a recommendation from Europe's Committee for Medicinal Products for Human Use (CHMP) for a proposed update to the labelling of its drug Tysabri.

The European Medicines Agency committee has issued a positive opinion on the application by Biogen Idec and partner Elan to include anti-JC virus antibody status as an additional risk factor for the multiple sclerosis treatment.

If approved, this new labelling will make it easier to stratify the risk of progressive multifocal leukoencephalopathy among prospective Tysabri patients.

In addition, the CHMP has also offered a recommendation that the drug should have its marketing authorisation renewed for a further five years.

Dr Douglas Williams, executive vice-president for research and development at Biogen Idec, added: "By identifying and understanding the multiple factors that are part of the benefit-risk equation, patients can be informed and empowered to engage in a discussion with their physician about choosing the right therapy."

Earlier this month, the firm published positive clinical trial data from a phase III study of a promising new multiple sclerosis treatment named BG-12.