Ublituximab-xiiy, developed by TG Therapeutics, will be sold under the name Briumvi.
The FDA recently approved ublituximab-xiiy for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
The drug will be sold as Briumvi. Approval was granted to TG Therapeutics.
The company said ublituximab is the first and only anti-CD20 monoclonal antibody approved for patients with RMS that can be administered in a 1-hour infusion following the starting dose. The administration schedule of consists of a day 1 infusion of 150mg administered in 4 hours, a day 15 infusion of 450mg administered in 1 hour, followed by 450mg infusions every 24 weeks administered in 1 hour.
Approval was granted based on data from the ULTIMATE I & II phase 3 trials, which demonstrated superiority over teriflunomide in significantly reducing the annualized relapse rate (ARR), the number of T1 gadolinium (Gd)-enhancing lesions, and the number of new or enlarging T2 lesions, according to the company.
The 2 randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials, with identical designs, treated patients with RMS for 96 weeks. The trials enrolled a total of 1094 patients in 10 countries.
Patients were randomized to receive either ublituximab, given as an IV infusion of 150 mg administered in 4 hours, 450 mg 2 weeks after the first infusion administered in 1 hour, and 450 mg every 24 weeks administered in 1 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 same schedule as ublituximab.
Both studies enrolled patients who had experienced at least 1 relapse in the previous year, 2 relapses in the previous 2 years, or had the presence of a T1 Gd-enhancing lesion in the previous year. Patients were also required to have an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline.
The therapy led to an "annualized relapse rate of less than 0.10, which translates to less than 1 relapse in 10 years," stated Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University, who led the trials. "This approval is great news for patients living with MS and provides an appealing treatment alternative that can be administered in a 1-hour infusion twice-a-year following the starting dose, which I believe is an added benefit to patients."