TG Therapeutics, Inc. 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 US for adult patients with RMS that can be administered in a one-hour infusion following the starting dose. Briumvi was granted approval by the US 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
