Roche, the makers of ocrelizumab have today announced that the Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for the use of ocrelizumab in adults with active relapsing remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS).
The positive CHMP opinion is based on data from three pivotal Phase III studies, which met key primary and secondary endpoints. Data from two identical Phase III studies in relapsing forms of MS (OPERA I and OPERA II) showed ocrelizumab demonstrated superior efficacy on reducing the number of relapses per year by nearly half and significantly slowed the risk of progression of the disease compared with comparative control groups over the two-year controlled treatment period. Additionally, ocrelizumab was shown to significantly reduce new brain lesions measured by MRI in both studies.
In a separate PPMS Phase III study (ORATORIO), ocrelizumab was the first and only treatment in a study of this size to significantly slow disability progression and reduce signs of disease activity in the brain (MRI lesions) within this patient population, compared with placebo with a median follow-up of three years.
'Today’s positive opinion on ocrelizumab is great news for people in the UK with MS who are now one step closer to having this important new treatment option,' said Professor Gavin Giovannoni, Chair of Neurology at Barts and The London School of Medicine and Dentistry. 'Controlling clinical and sub-clinical disease activity as early as possible is an important treatment goal for people living with MS. The clinical trial data demonstrate that ocrelizumab consistently impacts disease progression and has the potential to change how we approach treating both relapsing and early primary progressive forms of MS. If licensed, ocrelizumab will be a much-welcomed new treatment option for people with MS in the UK and has the potential to greatly simplify MS treatment.’'
Ocrelizumab has already been licensed for use in countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia and Switzerland.
Based on this positive CHMP opinion, a final decision from the European Commission regarding the licence of ocrelizumab is expected in the coming months. Following a positive Commission Decision, ocrelizumab will then be granted marketing authorisation that will be valid across the European Economic Area member states.