Biogen receives CHMP backing for Tysabri label update

Biogen has announced that its multiple sclerosis drug Tysabri has been recommended for EU approval in a new indication.

The Committee of Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of a variation to the marketing authorisation of Tysabri, based on the clinical evidence.

It would allow the drug to be used as a disease-modifying therapy for relapsing-remitting multiple sclerosis patients with highly active disease activity despite a full and adequate course of treatment with at least one disease-modifying therapy.

Long-term real-world experience from the Tysabri Observational Program, an ongoing ten-year prospective study, has shown the therapy can significantly reduce multiple sclerosis disease activity and offers a favourable benefit-risk profile.

Ralph Kern, senior vice-president for Biogen's worldwide medical business, said: "This update to the European marketing authorisation would allow patients with highly active disease to switch to Tysabri regardless of the prior disease-modifying therapy used."

A final decision from the European Commission is now expected in the coming months.