The European Commission has granted marketing authorization for ocrelizumab (Ocrevus) for the treatment of both active relapsing MS and early active primary progressive multiple sclerosis. This follows a recommendation from the European Medicines Agency in November that a licence should be granted.
- Active relapsing MS means people who are having relapses or showing new lesions on MRI scans
- Early primary progressive MS is defined as people who have had symptoms of MS for 15 years or less, have an EDSS of 3.0 to 6.5 and evidence of MS activity on MRI scans
"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
Ocrelizumab will now need to be appraised by NICE and the SMC to determine NHS availability in the UK. NICE has started the process and the MS Trust is contributing to the appraisal. A decision from NICE for relapsing MS is expected to be published in July 2018, with the drug potentially available on the NHS in England and Wales three months later. A decision from NICE for primary progressive MS is expected to be published later in 2018.
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.