Ublituximab is an experimental therapy that is not yet approved to treat multiple sclerosis. It is designed to eliminate B-cells, a type of immune cell that plays a central role in MS-driving inflammation. In clinical trials, it significantly reduced relapse rates, slowed disability progression, and prevented the development of new brain lesions.
Ublituximab showed promising results in two identical Phase 3 trials in relapsing forms of multiple sclerosis. The U.S. Food and Drug Administration is currently reviewing an application for approval for ublituximab based on those findings. A decision is expected by Sept. 28.
Clinical trials of ublituximab did not include pregnant or breastfeeding patients, so it is not known whether ublituximab is safe for use in these patients.
In ublituximab clinical trials, the treatment induced a rapid and marked depletion of B-cells within two weeks after the first dose. The earliest signs of benefits were reported at six months, with patients receiving ublituximab in a small Phase 2 trial showing significant reductions in active and total brain lesions at that point.
Neither hair loss nor weight gain has been reported as a side effect of ublituximab in multiple sclerosis clinical trials. Other anti-CD20 monoclonal antibodies also generally do not cause these side effects. Patients who experience unanticipated effects after starting a new MS therapy are advised to talk to their healthcare team.
Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.