Biogen Idec receives EU approval for Tysabri label update

Biogen Idec and partner Elan have been granted approval to update the risk stratification labelling on Tysabri, their successful multiple sclerosis (MS) treatment.

The European Commission has ratified a change to the summary of product characteristics to include anti-JC virus antibody status as a means of gauging the risk of patients developing progressive multifocal leukoencephalopathy.

According to the manufacturers, this information will help to empower physicians to make more educated decisions about whether patients can benefit from the drug.

In addition to this ruling, the European regulator also approved the ongoing safety, efficacy and quality of Tysabri, renewing its EU marketing authorisation status for another five years.

Dr Douglas Williams, executive vice-president for research and development at Biogen Idec, said: "For half a decade, Tysabri has benefited thousands of patients worldwide, offering hope for those in need of a powerful therapy to treat their MS."

This comes after the company was granted European regulatory backing for its Avonex Pen intramuscular autoinjector treatment system for MS earlier this month.