Posted by Michael Wonder on 16 Aug 2017
Health Canada approves Ocrevus (ocrelizumab) for Canadians living with relapsing-remitting multiple sclerosis
15 August 2017 - Ocrevus is a first-in-class treatment that targets B-cells, offering a new pathway to treat multiple sclerosis.
Roche Canada today announced that Health Canada has approved Ocrevus (ocrelizumab) for the treatment of adult patients with relapsing remitting multiple sclerosis with active disease defined by clinical and imaging features.
The approval of Ocrevus is based on the pivotal phase III, OPERA I & II studies, in which safety and efficacy were evaluated. Ocrevus demonstrated superior efficacy on the three major markers of disease activity by reducing relapses per year by nearly half (46% and 47% form OPERA I & II, respectively), slowing the worsening of disability and significantly reducing MRI lesions compared with the standard of care (high-dose interferon beta-1a) over the two-year controlled treatment period.
