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TG Therapeutics Announces FDA Approval of BRIUMVI™ (ublituximab-xiiy)
BRIUMVI is the first and only anti-CD20 monoclonal antibody approved for patients with relapsing forms of multiple sclerosis that can be administered in a
About this update from Tg Therapeutics, Inc.
[{"type":"text","content":"BRIUMVI is the first and only anti-CD20 monoclonal antibody approved for patients with relapsing forms of multiple sclerosis that can be administered in a one-hour infusion twice-a-year following the starting dose U.S. Commercial launch expected Q1 2023 Company to host conference call on Thursday, December 29, 2022 at 8:30 AM ET A Media Snippet accompanying this announcement is available by clicking on the image or link below: NEW YORK, Dec. 28, 2022 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the U.S. Food and Drug Administration (FDA) has approved 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. Approval was granted for this indication 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 recently published in August 2022 in The New England Journal of Medicine. 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 administration schedule of BRIUMVI consists of a day one infusion of 150mg administered in four hours, a day 15 infusion of 450mg administered in one hour, followed by 450mg infusions every 24 weeks administered in one hour. Michael S. Weiss, the Company's Chairman and Chief Executive Officer, stated, \"Today’s FDA approval marks an exciting day for everyone touched by MS and everyone that has worked on the development of BRIUMVI. We believe in the importance of treatment alternatives for patients and believe the profile of BRIUMVI offers unique attributes to patients and physicians alike. We have built a strong commercial team with deep knowledge of the MS landscape and look forward to launching in Q1 2023.” Mr. Weiss continued, “We want to thank the patients and their families, the clinical investigators and their teams, and our advisors for their support and participation in our trials, and for helping us get to this point. We remain committed t...