Ocrevus, a new drug for multiple sclerosis, arrives in Korea

Roche’s multiple sclerosis (MS) drug Ocrevus (ocrelizumab) won approval in Korea on Monday, the Ministry of Food and Drug Safety (MFDS) said.

MS is a chronic disease of the central nervous system, consisting of the brain, spinal cord, and optic nerves. It is an autoimmune disease where the patient's immune system attacks healthy cells and tissues.

Ocrevus is a recombinant humanized monoclonal antibody (mAb, IgG1) that selectively targets B cells expressing CD20 (a cell surface antigen expressed on pre-B cells, mature and memory B cells, but not on lymphocyte stem cells, and plasma cells) to inhibit MS by reducing the number and function of B cells.

According to Roche Korea, Ocrevus is a treatment administered as an initial 600 mg divided into two intravenous infusions, followed by a single 600 mg intravenous infusion every six months.

"We expect this drug to provide a new treatment opportunity for patients with relapsing-remitting MS and primary progressive MS,” the ministry said. “We will continue to do our best to ensure that treatments with sufficiently confirmed safety and effectiveness are quickly available based on our regulatory science expertise."