A new treatment for relapsing multiple sclerosis (MS) has been commercially launched. The treatment called ublituximab-xiiy, which will be sold under the brand name Briumvi is indicated for adult patients with clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.
“Our team has been working hard to make BRIUMVI available as quickly as possible, and we are pleased to announce that BRIUMVI is now available to healthcare providers and patients,” said Michael S. Weiss, the chairman and chief executive officer of TG Therapeutics, the makers of the treatment in a press release.
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“We continue to be highly focused on ensuring patients who can benefit from BRIUMVI can easily access treatment. We have built what we consider to be a best-in-class team to support this launch, as well as a robust patient support program designed to aid in accessing BRIUMVI at all points through the treatment journey,” he added.
Ublituximab-xiiy is a novel monoclonal antibody targeting CD20-expressing B-cells. Because it lacks certain sugar molecules normally expressed on the antibody, ublituximab-xiiy can deplete B-cells even at low doses. It can be administered as an infusion lasting 1 hour following the starting dose.
The treatment was approved by the US Food and Drug Administration based on results from 2 phase 3 clinical trials showing that it is superior to teriflunomide (Aubagio) – a pyrimidine synthesis inhibitor also used to treat relapsing MS – in reducing the annualized relapse rate as well as the number of T1 Gd-enhancing and new or enlarging T2 lesions.
Ublituximab-xiiy is the only anti-CD20 monoclonal antibody approved for patients with relapsing MS.
The launch is accompanied by a patient support program offered by TG Therapeutics to support patients through their treatment journey with ublituximab-xiiy.
TG Therapeutics announces commercial launch of BRIUMVI™ (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis. News release. TG Therapeutics; January 26, 2023