Health Canada has approved Hoffman-La Roche’s Ocrevus for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS).
Also known as Ocrelizumab, the medication is a humanized anti-CD20 monoclonal antibody which depletes B-cells carrying the CD20 molecule which is believed to be involved in the process which causes brain damage in MS patients.
The Health Canada approval of Ocrevus this week follows the approval of the drug by the United States Food and Drug Administration back in March. The drug became available in the U.S. in April.
The drug is priced at US$65,000 for two annual infusions per year.
The approval of Ocrevus by Health Canada was based on the pivotal phase III, OPERA I & II studies, in which safety and efficacy were evaluated.
The drug demonstrated superior efficacy on the three major markers of disease activity by reducing relapses per year by nearly half (46 per cent and 47 per cent form OPERA I & II, respectively). It slowed 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, according to Roche.
Ocrevus binds to a CD-20 found on some B-cells that would otherwise attack the protective layer around the brain’s nerve fibers.
Ocrevus does not bind to stem cells or plasma cells, maintaining the capacity of B-cells to rebuild and therefore important functions of the immune system are preserved.
Multiple Sclerosis is a chronic disease in which the immune system abnormally attacks components of myelin, causing inflammation and consequent damage.
Approximately 100,000 Canadians living with MS6 and RRMS is the most common form, characterized by clearly defined attacks of new or worsening neurologic symptoms. In patients with MS, damaged nerves lose their ability to communicate with the rest of the body, leading to unpredictable and often debilitating symptoms such as weakness, fatigue, and vision problems.
“Ocrevus is a major addition to the treatment options available for MS,” said Dr. Daniel Selchen, neurologist and head of the Division of Neurology at St. Michael’s Hospital in Toronto. “The RRMS Ocrevus clinical trial data show a significant reduction in relapses and disease progression, as well as a good safety profile.”
“For appropriate patients, Ocrevus will be of great value in reducing the burden of MS,” Selchen said.
August 18, 2017