Abstract
Ocrelizumab (Ocrevus) is a humanized monoclonal antibody that was approved by the US Food and Drug Administration (FDA)on 28th March 2017 for the treatment of relapsing remitting multiple sclerosis (RRMS) and primarily progressive multiple sclerosis(PPMS) approved immunomodulatory treatment. European Medicines Agency (EMA) has recommended 10th November 2017OCR for the treatment of adult RRMS patients and early primary progressive MS patients in the European Union (EU) countries.In the Czech Republic, OCR was registered on 8th January 2017.
The treatment is focused on mature B lymphocytes, immune cellsexpressing the protein CD20 molecule on their surface. It is believed that these CD20-positive B-lymphocytes are directed againstthe axons and myelin of healthy neurons, initiating a cascade of immune responses that lead to their damage and consequentlyto the disability in MS patients.
This new view on MS pathogenesis was supported by evidence from a phase III, OPERA I, OPERAII and ORATORIO clinical trial.