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Ocrelizumab recommended for licensing by European Medicines Agency

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The European Medicines Agency recommends licensing for ocrelizumab (Ocrevus) for treating relapsing and primary progressive MS.

The European Medicines Agency (EMA) has recommended that a licence should be granted for ocrelizumab for the treatment of both active relapsing MS and early active primary progressive MS.

The recommendation states:

"Ocrevus is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.

Ocrevus is indicated for the treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity."

"This is exciting news, especially for people with progressive MS as ocrelizumab is the first drug to be licensed for primary progressive MS in Europe. 

We hope that the availability of a new treatment will lead to a renewed focus on the needs of all people with progressive MS and improve their access to services."

Jo Sopala, Director of Development 

The next step in the approval process is for the European Commission to grant the licence, taking into the consideration the EMA's recommendation. Ocrelizumab will then be appraised by NICE and SMC to determine availability in the UK.

NICE has already started the appraisal process for both uses of ocrelizumab and decisions are expected to be published mid 2018. The MS Trust is contributing to the appraisals. If NICE approves the use of ocrelizumab, it could be available on the NHS towards the end of 2018.

About ocrelizumab

Ocrelizumab is taken as an intravenous infusion (drip). The first dose is given as two separate infusions, two weeks apart. Further doses are given as one infusion every six months.

In clinical trials for relapsing MS, ocrelizumab reduced the risk of relapses by 50% compared to beta interferon (Rebif), reduced disability progression and the number of lesions seen on MRI scans.

For primary progressive MS, people taking ocrelizumab were 24% less likely to experience increased disability compared to those taking placebo.

Across all the clinical trials, infusion-related reactions, chest infections and herpes (oral herpes and shingles) were more frequent in those taking ocrelizumab.

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