Biogen Idec and its partner Elan Corporation have applied for approval of their multiple sclerosis (MS) therapy Tysabri in a new indication.
Applications have been submitted to the US Food and Drug Administration and European Medicines Agency requesting updates to the Tysabri label that would include first-line use for patients with certain relapsing forms of MS who have tested negative for antibodies to the JC virus.
“Biogen Idec and Elan Corporation have applied for EU and US regulatory approval for Tysabri in a new indication for multiple sclerosis.“
These submissions are supported by risk stratification data and a risk algorithm that enables physicians and individuals living with MS to make informed decisions when considering Tysabri treatment.
Dr Alfred Sandrock, senior vice-president for development sciences and chief medical officer at Biogen Idec, said: "A first-line approval would allow people with MS access to a highly efficacious treatment earlier in the course of the disease, potentially leading to better outcomes."
To date, Tysabri has been approved for use in more than 65 countries and has been shown in clinical studies to reduce flare-ups and slow physical disability progression among those affected by the illness.