TG Therapeutics’ Briumvi (ublituximab-xiiy) Receives the US FDA’s Approval for Relapsing Multiple Sclerosis
- The US FDA has approved Briumvi for adult patients with RMS incl. clinically isolated syndrome, relapsing-remitting disease & active secondary progressive disease. The product is expected to be available in the US from Q1’23
- The approval was based on the P-III trials (ULTIMATE I & II) results evaluating Briumvi (IV Day 1 (150mg), Day 15 (450mg), followed by 450mg, q24w) vs teriflunomide (14mg, qd) in 1094 patients for 96wks. across 10 countries
- The results showed superiority over teriflunomide, the relative reduction in ARR in both trials (59% & 49%); no. of T1 Gd-enhancing/MRI (97% & 97%); T2 hyperintense lesions/MRI (92% & 90%), patients with 12wk. confirmed disability progression (5.2% vs 5.9%) in the combined trial
Ref: TG Therapeutics | Image: TG Therapeutics
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