Ublituximab

Ublituximab, sold under the brand name Briumvi, is an immunomodulator used for the treatment of multiple sclerosis. It is a CD20-directed cytolytic monoclonal antibody.

The most common adverse reactions include infusion reactions, including fever, chills, headache, influenza-like illness, elevated heart rate, nausea, throat irritation, reddening of the skin (erythema) and an anaphylactic (allergic) reaction; infections including serious and fatal bacterial, fungal, and new or reactivated viral infections and reduction in immunoglobulins.

It was approved for medical use in the United States in December 2022, and in the European Union in May 2023.

Ublituximab is indicated for the treatment of relapsing-remitting, active secondary progressive, and clinically isolated syndrome forms of multiple sclerosis in adults.

In the European Union, ublituximab is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.

Ublituximab was designed as part of a research program initiated more than fifteen years ago by the French Laboratory of Fractionation and Biotechnology (LFB), with the initial objective of addressing a clinical need in chronic B-lymphocytic leukemia (B-CLL). The design of ublituximab has been optimized to enhance the activation of killer immune cells while minimizing side effects, through modifications to its structure and glycosylation. After initial clinical trials confirming its strong cytotoxic activity and ability to eliminate B cells, the development of ublituximab was pursued by the American biopharmaceutical company TG Therapeutics, which then marketed it under the name Briumvi. Researchers demonstrated the efficacy of ublituximab in two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in participants with relapsing forms of multiple sclerosis treated for 96 weeks. Participants were randomized to receive either ublituximab or teriflunomide, the active comparator. The primary outcome of both studies was the annualized relapse rate over the treatment period. In both studies, ublituximab significantly lowered the annualized relapse rate compared to teriflunomide.

Ublituximab is the international nonproprietary name (INN).

• Clinical trial number NCT03277261 for "Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) (ULTIMATE 1)" at ClinicalTrials.gov
• Clinical trial number NCT03277248 for "Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) (ULTIMATE II)" at ClinicalTrials.gov