Monoclonal Antibody Treatment for Adults with Relapsing Forms of Multiple Sclerosis Launches

TG Therapeutics, Inc. today announced the commercial launch of BRIUMVI™, for treating relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.   

BRIUMVI is the first and only anti-CD20 monoclonal antibody (mAbs) approved for patients with RMS that can be administered in a one-hour infusion following the starting dose.

BRIUMVI targets a unique epitope on CD20-expressing B-cells and was designed to lack specific sugar molecules normally expressed on the antibody.

Removing these sugar molecules, a process called glycoengineering allows for efficient B-cell depletion at low doses.

BRIUMVI was approved by the U.S. Food & Drug Administration based on data from Phase 3 trials, which demonstrated superiority over teriflunomide in significantly reducing the annualized relapse rate (the primary endpoint), the number of T1 Gd-enhancing lesions and the number of new or enlarging T2 lesions.

Michael S. Weiss, the Company's Chairman and CEO stated in a press release on January 26, 2023, "Our team has been working hard to make BRIUMVI available as quickly as possible, and we are pleased to announce that BRIUMVI is now available to healthcare providers and patients."

"We continue to be highly focused on ensuring patients who benefit from BRIUMVI can easily access treatment."

RMS is a chronic demyelinating disease of the central nervous system. It includes people with relapsing-remitting multiple sclerosis and people with secondary progressive multiple sclerosis who continue to experience relapses.

The results from the ULTIMATE I & II trials were published on August 25, 2022, in The New England Journal of Medicine.

The launch of BRIUMVI includes an extensive patient support program designed to support patients through their treatment journey. More information about the BRIUMVI Patient Support program can be accessed at www.briumvi.com.

TG Therapeutics was founded with one goal in mind—to leverage scientific advances in B-cell biology to develop novel treatments for patients.