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Ublituximab is an investigational targeted B-cell therapy that shows superior efficacy when compared with teriflunomide, a commonly prescribed oral treatment for multiple sclerosis
ULTIMATE I and II demonstrated significant reductions in risk of relapses, as well as reduction of active or new brain lesions
The US Food and Drug Administration and European Medicines Agency are currently reviewing marketing applications for ublituximab for the treatment of relapsing forms of multiple sclerosis (RMS) in adults
If approved, ublituximab will be the first B-cell therapy for use in RMS patients that can be given as a 1- hour infusion every 6 months, following the first dose
NEW YORK, Aug. 25, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced results from the ULTIMATE I & II Phase 3 trials evaluating ublituximab, the Company’s investigational anti-CD20 monoclonal antibody, in patients with relapsing forms of multiple sclerosis (RMS), were published in The New England Journal of Medicine (NEJM). Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “We are extremely pleased that the results from the ULTIMATE I & II trials have been published in The New England Journal of Medicine. We believe ublituximab’s novel mechanism of action, coupled with the convenience of a one-hour infusion represents a potential advance for patients with RMS and we are pleased that this publication will share the ULTIMATE I and II data with a broad audience. We continue to be singularly focused on working toward the potential approval of ublituximab by the December 28, 2022 PDUFA goal date, and if successful, being prepared to launch early next year. We once again want to thank the patients that participated in ULTIMATE I and II and the healthcare providers at the sites that worked so hard on these trials.”
Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University and Global Study Chair for the ULTIMATE I & II trials stated, “The ULTIMATE trials found ublituximab treatment, compared to teriflunomide, produced significantly lower annualized relapse rates, reduction in the total number of MRI-detectable lesions, as well as improved rates of patients achieving no evidence of disease activity (NEDA). If approved, the unique attributes of ublituximab, particularly its ability to be infused in a one-hour infusion every six months following the first dose, may offer benefits to patients with relapsing forms of multiple sclerosis.” Key Data from the ULTIMATE I & II Trials
Primary Endpoint: Annualized Relapse Rate (ARR) Results
