CHMP recommends Briumvi to treat relapsing forms of multiple sclerosis.- Propharma Group The Netherlands B.V. + TG Therapeutics
Briumvi will be available as a 150 mg concentrate for solution for infusion. The active substance of Briumvi is ublituximab, a selective immunosuppressant (ATC code: L04AG14) that selectively targets CD20-expressing B-cells involved in the inflammatory changes in the central nervous system of patients with multiple sclerosis.
The benefits of Briumvi are a 49-59% reduction in the annual relapse rate and a greater than 90% reduction in the number of acute inflammatory lesions (97% of Gd-enhancing T1 lesions and 90-92% T2 hyperintense lesions per MRI scan), compared with teriflunomide in two Phase III, randomised, double-blind, active-controlled clinical trials in patients with relapsing multiple sclerosis. The most common side effects are infusion-related reactions and infections.