EU approves Briumvi in adults with relapsing multiple sclerosis – TG Therapeutics

TG Therapeutics announced that the European Commission (EC) has granted approval of Briumvi (ublituximab xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. Briumvi was granted approval by the FDA on December 28, 2022, for the treatment of RMS in adults. Briumvi is the first and only anti-CD20 monoclonal antibody approved in the U.S. and now the European Union (EU) for adult patients with RMS that can be administered in a one-hour infusion following the starting dose.

The EC approval is based on data from the ULTIMATE I & II Phase III 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 (previously cited).