Ocrelizumab is currently being assessed for drug licensing by the EMA (European Medicines Agency) for both relapsing remitting and primary progressive MS. It will then be appraised for cost and effectiveness as an NHS treatment for both types of MS. If these steps are successful ocrelizumab could be available on the NHS by 2018 at the earliest. The FDA decision does not affect the European assessment.
Pam Macfarlane, Chief Executive of the MS Trust commented:
This is an encouraging step forward for people with PPMS in the USA. Though the UK is part of a separate licensing process in Europe and there is still a long way to go, the FDA decision is a cause for optimism. The MS Trust will keep watching how things are developing here and provide updates when we can. We are well aware how important this new medicine could be for people with PPMS.
Ocrelizumab is taken as an intravenous infusion (drip) every six months. It reduces the number of B cells, a type of white blood cell, or lymphocyte thought to be involved in the abnormal immune response that attacks the myelin coating of nerve cells.
- In primary progressive MS, people taking ocrelizumab were 24% less likely to have an increase in their disability than those taking placebo
- In relapsing remitting MS, ocrelizumab reduced relapse rates by approximately 50% compared to beta interferon
- Infusion-related reactions, chest infections and herpes (oral herpes and shingles) were more frequent in those taking ocrelizumab
- Neoplasms (abnormal growth of tissues which can be benign or malignant), including several cases of breast cancer, were reported more frequently in those taking ocrelizumab