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TG Therapeutics Announces Positive CHMP Opinion for BRIUMVI™ (ublituximab-xiiy) for the Treatment of Relapsing Forms of Multiple Sclerosis in Adults
NEW YORK, March 31, 2023 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the Committee for Medicinal Products for Human Use
About this update from Tg Therapeutics, Inc.
[{"type":"text","content":"NEW YORK, March 31, 2023 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of BRIUMVI™ (ublituximab-xiiy) for the treatment of adult patients relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. BRIUMVI is the first and only anti-CD20 monoclonal antibody approved in the U.S. for adult patients with RMS that can be administered in a one-hour infusion following the starting dose. BRIUMVI was granted approval by the U.S. Food and Drug Administration on December 28, 2022, for the treatment of RMS in adults. Michael S. Weiss, the Company's Chairman and Chief Executive Officer, stated, \"The positive recommendation to approve BRIUMVI by the CHMP takes us one step closer to delivering BRIUMVI to patients and healthcare providers in Europe. Following today’s recommendation, we look forward to hearing a decision on the marketing authorization application by the European Commission in the coming months.” Hans-Peter Hartung, MD, PhD, FRCP, Professor of Neurology at Heinrich-Heine University Düsseldorf and Steering Committee Member for the ULTIMATE I & II trials stated, “Today’s announcement from the CHMP marks an important milestone for patients living in the EU with MS, a chronic condition affecting millions worldwide. The data from the ULTIMATE I & II trials establish BRIUMVI as an effective MS treatment which can be administered in a one-hour infusion twice a year following the starting dose. I look forward to the potential approval of BRIUMVI and it being available to those in need of treatment alternatives in the EU.” The positive CHMP Opinion is 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. Based on the CHMP recommendation, a decision by the European Commission is expected in approximately two months. If granted by the European Commission, the centralised marketing authoris...