European Medicines Agency recommends market authorisation for ocrelizumab (Ocrevus) in EU

The European Medicines Agency (EMA) has recommended granting a marketing authorisation in the European Union (EU) for ocrelizumab (Ocrevus) for the treatment of adult patients with relapsing multiple sclerosis (RMS) and early primary progressive multiple sclerosis (PPMS).

Ocrelizumab is the first disease-modifying therapy for PPMS, making it a crucial step forward for more effective treatments for people with PPMS. The EMA recommendation follows approval of ocrelizumab for countries in the United States, Australia and Switzerland.

The EMA is recommending that for PPMS, ocrelizumab should only be prescribed for people with early PPMS, according to the duration of their MS symptoms, their level of disability and whether their MRI results indicate inflammatory activity. The EMA notes that more investigation is required before this treatment can be recommended for people in more advanced stages of disability.

The opinion will now be sent to the European Commission, for a decision on an EU-wide marketing authorisation. Decisions about price and reimbursement will take place at the level of each member state in the context of the national health system of that country.

MSIF will continue to work together in the International Progressive MS Alliance towards accelerating the development of treatment for everyone living with progressive MS.

Various MS organisations in Europe have responded publicly to the news, including some of MSIF’s member organisations – the UK MS Society and the German MS Society.