A license for the drug OCREVUS® (ocrelizumab) has been granted by the European Commission for use in patients with primary progressive multiple sclerosis (PPMS) and the more common relapsing-remitting form (RRMS). Previously, no treatments have been approved for PPMS, the most debilitating type of the disease. Ocrelizumab is a humanized monoclonal antibody designed to target cells expressing CD20 antigens, primarily B cells, which are thought to be major contributors to the damage of axons and myelin. By reducing damage exerted on myelin, it is thought that ocrelizumab may protect against the nerve damage that leads to disability in multiple sclerosis.
The approval comes after completion of randomized, double-blind, multi-center global Phase III trials, carried out by Roche (Basel, Switzerland). The studies examined a total of 732 RRMS patients and 1656 individuals with PPMS. 600mg of ocrelizumab was administered intravenously to the participants every 6 months, compared with subcutaneous interferon beta-1a.
The drug demonstrated improved clinical efficacy for three major markers of the disease when compared with interferon beta-1a. The total number of annual relapses decreased by nearly 50% as a result of ocrelizumab treatment over the 2 year trial period, with the number of new brain lesions observed in MRI also being reduced.
PPMS is known to exhibit rapid advancement of disease pathology, with physical disability accumulating faster than in RRMS. Patients often have to rely on wheelchairs and other motility aids and may become unable to work or live independently; hence therapy to offset symptoms is urgently needed. The more common type, being diagnosed in 85% of multiple sclerosis cases, RRMS continues to cause increasing disability in many, despite advances in treatment options.
The drug has now been approved for use in several countries throughout Europe, North and South America and Australia. The news brings hope for a treatment with the potential to improve quality of life for thousands of PPMS sufferers, as summarized by Sandra Horning, Chief Medical Officer and Head of Global Product Development, Roche: “For people in Europe living with MS, today’s approval of OCREVUS by the European Commission signifies an important advance in the treatment of their disease…We are committed to working with member states to provide access as quickly as possible to people with RMS and PPMS who may benefit from OCREVUS.”
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