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Roche's Ocrevus gets the go ahead in Europe for two forms of MS

Published on 12/01/18 at 09:50am

Roche has revealed that its multiple sclerosis (MS) drug Ocrevus (ocrelizumab) has been awarded marketing approval in Europe by the European Commission. The therapy is now indicated for the treatment of active relapsing forms of the disease in patients as defined by clinical or imaging features, as well as for patients with early primary progressive forms of MS in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity.

The EC’s decision to approve the drug was based on positive data from three Phase 3 studies comprising 2,388 patients. The study programme demonstrated that around 80% of patients experienced superior efficacy with Ocrevus compared to Rebif (interferon beta-1a) over two years, as well as a “significantly” slower disease progression. The drug also increased the chances of a patient having no evidence of disease activity by 64% in one trial and 89% in another compared to Rebif.

In the third trial, Roche noted that Ocrevus was the first and only therapy to significantly slow disability progression and reduce signs of MRI lesions in the brain compared with placebo, while patients treated with the drug were 24% less likely to see disease progression for three months, and 25% for six months.

“It is great news that Ocrevus, which has the potential to be a significant game changer in how we think about and treat MS, has been approved in the European Union today,” said Gavin Giovannoni, Professor of Neurology at Barts and The London School of Medicine and Dentistry, Queen Mary University of London. “Until Ocrevus, people with primary progressive MS, who often have to rely on a cane or wheelchair, give up work or have carers look after them, have not had an approved treatment to slow the progression of their disease. 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.”

Around 700,000 people in Europe are affected by MS, with around 96,000 of that number possessing a progressive form.

Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development, also commented on the EC’s decision: “For people in Europe living with MS, today’s approval of Ocrevus by the European Commission signifies an important advance in the treatment of their disease. Ocrevus is the first medicine to be approved for primary progressive MS, a debilitating form in which irreversible disability accumulates rapidly, and it provides a highly efficacious treatment option for people with relapsing forms of MS. We are committed to working with member states to provide access as quickly as possible to people with RMS and PPMS who may benefit from Ocrevus.”

Matt Fellows

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