TG Therapeutics Announces Commercial Launch of BRIUMVI™ (ublituximab-xiiy) for the Treatment of Adult Patients with Relapsing Forms of Multiple Sclerosis

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[{"type":"text","content":"NEW YORK, Jan. 26, 2023 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the commercial launch of BRIUMVI™ (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 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. Michael S. Weiss, the Company's Chairman and Chief Executive Officer, stated, \"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.” Mr. Weiss continued, “We continue to be highly focused on ensuring patients who can benefit from BRIUMVI can easily access treatment. We have built what we consider to be a best-in-class team to support this launch, as well as a robust patient support program designed to aid in accessing BRIUMVI at all points through the treatment journey. We encourage those interested to visit www.briumivi.com to learn more and also find the full prescribing information.” BRIUMVI was granted approval by the U.S. Food & Drug Administration based on data from the ULTIMATE I & II Phase 3 trials, which demonstrated superiority over teriflunomide in significantly reducing the annualized relapse rate (ARR, the primary endpoint), the number of T1 Gd-enhancing lesions and the number of new or enlarging T2 lesions. Results from the ULTIMATE I & II trials were published in August 2022 in The New England Journal of Medicine. ABOUT THE ULTIMATE I & II PHASE 3 TRIALSULTIMATE I & II are two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either BRIUMVI, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour, w...

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