Based on ULTIMATE I & II trial results, novel drug BRIUMVI gets USFDA approval for relapsing forms of multiple sclerosis patients

TG Therapeutics recently announced the U.S.Food and Drug Administration (FDA) has approved BRIUMVI (ublituximab-xiiy),for the treatment of relapsing forms of multiple sclerosis (RMS), to includeclinically isolated syndrome, relapsing-remitting disease, and active secondaryprogressive disease, in adults.

Approval was granted for this indication basedon data from the ULTIMATE I & II Phase 3 trials, which demonstratedsuperiority over teriflunomide in significantly reducing the annualized relapserate (ARR, the primary endpoint), the number of T1 Gd-enhancing lesions and thenumber of new or enlarging T2 lesions. Results from the ULTIMATE I & IItrials were recently published in August 2022 in The New England Journal of Medicine.

BRIUMVI is the first and only anti-CD20monoclonal antibody approved for patients with RMS that can be administered ina one-hour infusion following the starting dose. The administration schedule ofBRIUMVI consists of a day one infusion of 150mg administered in four hours, aday 15 infusion of 450mg administered in one hour, followed by 450mg infusionsevery 24 weeks administered in one hour.

ULTIMATE I & II are two randomized,double-blind, double-dummy, parallel group, active comparator-controlledclinical trials of identical design, in patients with RMS treated for 96 weeks.Patients were randomized to receive either BRIUMVI, given as an IV infusion of150 mg administered in four hours, 450 mg two weeks after the first infusionadministered in one hour, and 450 mg every 24 weeks administered in one hour,with oral placebo administered daily; or teriflunomide, the active comparator,given orally as a 14 mg daily dose with IV placebo administered on the sameschedule as BRIUMVI. Both studies enrolled patients who had experienced atleast one relapse in the previous year, two relapses in the previous two years,or had the presence of a T1 gadolinium (Gd)-enhancing lesion in the previousyear. Patients were also required to have an Expanded Disability Status Scale(EDSS) score from 0 to 5.5 at baseline. The ULTIMATE I & II trials enrolleda total of 1,094 patients with RMS across 10 countries

Reference:

BRIUMVI prescribing information,TGTherapeutics NY

STeinman L et al,ublituximab versusteriflunomide in relapsing multiple sclerosis,10.1056/NEJMoa2201904

DATA on file,TG Therapeutics NY