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Home Industry News Roche receives EU approval for multiple sclerosis drug Ocrevus

Roche receives EU approval for multiple sclerosis drug Ocrevus

15th January 2018

Roche has announced that its multiple sclerosis drug Ocrevus has received marketing authorisation from the European Commission.

The regulator has approved the drug for the treatment of active relapsing forms of multiple sclerosis, and for patients with early primary progressive multiple sclerosis, to be administered by intravenous infusion every six months.

It represents the first and only approved disease-modifying medicine in the EU for early primary progressive multiple sclerosis, and has been shown to significantly suppress three major markers of disease activity and disability progression.

This approval was supported by data from three large phase III studies, which demonstrated the favourable benefit-risk profile of Ocrevus among a diverse patient population, including those early in the disease.

Dr Sandra Horning, Roche's chief medical officer and head of global product development, said: "For people in Europe living with multiple sclerosis, today's approval of Ocrevus by the European Commission signifies an important advance in the treatment of their disease."

Multiple sclerosis affects approximately 700,000 people in Europe, of which around 96,000 have the highly disabling primary progressive form.

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