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
Related News:- TG Therapeutics Published P-III (ULTIMATE I & II) Trials Results of Ublituximab for RMS in the NEJM
