The European Commission (EC) has approved TG Therapeutics’ Briumvi (ublituximab-xiiy) to treat relapsing forms of multiple sclerosis (RMS) in adult patients.
Briumvi is an anti-CD20 monoclonal antibody indicated for RMS adult patients with active disease which is defined by clinical or imaging features.
It has been engineered to remove certain sugar molecules generally expressed on the antibody.
The therapy targets a unique epitope on CD20-expressing B-cells.
TG Therapeutics chairman and CEO Michael Weiss said: “We are very pleased that the European Commission has approved BRIUMVI for the treatment of adult patients with multiple sclerosis.
“This brings us one step closer to our goal of providing MS patients in Europe with an alternative treatment option that can be delivered in a one-hour infusion every six months following the starting dose and we are targeting commercial availability later this year.”
The regulatory approval is based on the findings obtained from the ULTIMATE I & II Phase III trials.
The two double-dummy, active comparator-controlled, randomised, double-blind, parallel-group clinical trials were designed for determining the annualised relapse rate (ARR) in RMS patients after 96 weeks of treatment with intravenous (IV) infusion of ublituximab, along with oral placebo compared to 14mg oral teriflunomide and IV placebo.
According to the findings, the treatment with Briumvi showed superior performance over teriflunomide in reducing the ARR, the number of new or enlarging T2 lesions, and the number of T1 Gd-enhancing lesions.
Last December, the US Food and Drug Administration (FDA) also granted approval to Briumvi to treat RMS in adult patients.
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