TG Therapeutics’ Briumvi (ublituximab-xiiy) Receives EC’s Approval for the Treatment of Relapsing Forms of Multiple Sclerosis
Shots:
- The EC has approved Briumvi for adult patients with RMS with active disease defined by clinical or imaging features. The approval was based on the P-III trials (ULTIMATE I & II) evaluating Briumvi vs teriflunomide in 1094 patients across 10 countries
- The trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University. The results demonstrated superiority over teriflunomide in reducing the ARR, the no. of T1 Gd-enhancing lesions, and new or enlarging T2 lesions
- Briumvi (anti-CD20 mAb) was approved in the US & EU for RMS that can be administered in 1hr. infusion following the starting dose. The centralized marketing authorization is valid in all EU Member States, Iceland, Norway & Liechtenstein
Ref: TG Therapeutics | Image: TG Therapeutics
Related News:- TG Therapeutics Receives EMA’s CHMP Positive Opinion of Briumvi (ublituximab-xiiy) for the Treatment of Relapsing Forms of Multiple Sclerosis
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