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December 28, 2022 – TG Therapeutics, Inc. has announced the U.S. Food and Drug Administration (FDA) has approved BriumviTM (ublituximab-xiiy) for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Briumvi is the first and only anti-CD20 monoclonal antibody approved for patients with RMS that can be administered in a one-hour infusion following the starting dose. The administration schedule of Briumvi consists of a day one infusion of 150 mg administered over four hours, a day 15 infusion of 450 mg administered in one hour, followed by 450 mg infusions every 24 weeks administered over one hour.
Briumvi is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders such as RMS. Briumvi is uniquely designed to lack certain sugar molecules normally expressed on the antibody. The removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.
Briumvi is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
- Active HBV infection
- A history of life-threatening infusion reaction to Briumvi