Monday November 13 2017 10:02 AM
Ocrelizumab recommended for licencing by European Medicines Agency for relapsing remitting and early primary progressive MS
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."
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 assessed by the National Centre for Pharmaco-economics (NCPE) in Ireland who will make a recommendation to the HSE about reimbursement.
MS Ireland will make a Patient Group Submission to the NCPE as part of this process and we will be doing everything we can to try and make this medication available to Irish people with MS as soon as possible.
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. Further information is available here