The EMA’s CHMP has issued a positive opinion recommending the approval of Briumvi for adult patients with RMS with active disease defined by clinical or imaging features. The EC’s decision is expected in ~2mos.
The opinion 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 showed superiority over teriflunomide in reducing the ARR, the no. of T1 Gd-enhancing lesions & new or enlarging T2 lesions. The results were published in the NEJM. The centralized marketing authorization was valid in all EU MEMBER States, Iceland, Norway & Liechtenstein
Ref: TG Therapeutics | Image: TG Therapeutics
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