Ocrelizumab has now also been approved in the EU for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical and imaging features.[1] This European approval in January 2018, followed two previous approvals in 2017, granted to Genentech, the developers,  initially in the US (March) [2] and later in Canada (August)[3] for the same indication.

This first-in-class agent targeting B-cells is administered as a single infusion every six months. This is a benefit to patients as explained by Gavin Giovannoni, Professor of Neurology at Barts and The London School of Medicine and Dentistry, Queen Mary University of London, when he stated that, “people with relapsing forms of MS often have to make difficult trade-off choices between safety and higher efficacy. OCREVUS is given every six months without the need for onerous monitoring, which we hope will allow people to live their lives without thinking about their treatment every day or every week.” [1]

The approval was based on results from the pivotal phase III studies from ORCHESTRA programme comprising two studies in patients with RRMS (OPERA I[4] and OPERA II[5]) and one trial in patients with Primary Progressive MS (ORATORIO).[6]

For further information about the first global approval of ocrelizumab in the US please visit the detailed review in Adis’ journal Drugs[7], based on the development milestones tracked in AdisInsight.[7]

Image credit: Ivelin Radkov / Fotolia

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