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NEW YORK, Sept. 30, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval of ublituximab, the Company’s investigational glycoengineered anti-CD20 monoclonal antibody, as a treatment for patients with relapsing forms of multiple sclerosis (RMS). The submission was based on the results of the ULTIMATE I & II trials, two identical Phase 3, randomized, global, multi-center, double-blinded, active-controlled trials evaluating ublituximab compared to teriflunomide in patients with RMS. The ULTIMATE I & II trials were conducted under a Special Protocol Assessment (SPA) agreement with the FDA.
Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “The submission of this BLA for ublituximab to treat patients with RMS marks a major milestone for us, being our first submission of a marketing application for an autoimmune indication and rounds out our near-term U.S. regulatory submissions. Multiple sclerosis is a chronic and potentially disabling disease that affects nearly 1 million Americans. We believe ublituximab has the potential to offer an important new treatment option for these patients, and we look forward to working closely with the FDA on this submission.” Mr. Weiss continued, “We want to thank the patients and their families, as well as the physicians and their research teams, who participated in our ULTIMATE I and II trials.”
ABOUT THE ULTIMATE I & II PHASE 3 TRIALSULTIMATE I and ULTIMATE II are two independent Phase 3, randomized, double-blinded, active-controlled, global, multi-center studies evaluating the efficacy and safety/tolerability of ublituximab (450mg dose administered by one-hour intravenous infusion every 6 months, following a Day 1 infusion of 150mg over four hours and a Day 15 infusion of 450mg over one hour) versus teriflunomide (14mg oral tablets taken once daily) in subjects with relapsing forms of Multiple Sclerosis (RMS). The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University and were conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). As previously announced, both studies met their primary endpoint with ublituximab treatment demonstrating a statistically significant reduction in annualized relapse rate (ARR) compared to teriflunomide over a 96-week period (p
