FDA approves new MS injection treatment

January 11, 2023
The FDA approved TG Therapeutics’ Briumvi (ublituximab-xiiy) injection treatment for patients with clinically isolated syndrome, relapsing-remitting, and active secondary progressive multiple sclerosis in adults. In clinical trials, Briumvi was found to significantly lower annualized relapse rates compared to Aubagio (teriflunomide). 

Briumvi is an anti-CD20 monoclonal antibody approved for patients with relapsing MS that can be administered in a one-hour infusion following the starting dose. The first dose will last about four hours. The second dose will be given two weeks after the first dose with the infusion lasting about one hour. Subsequent infusions will be given as one infusion every 24 weeks and will last about one hour. Briumvi will be available for ordering early 2023.

Researchers showed Briumvi’s effectiveness in two randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either Briumvi or teriflunomide, the active comparator. 

The most common adverse reactions were infusion reactions, including fever, chills, headache, influenza-like illness, elevated heart rate, nausea, throat irritation, reddening of the skin (erythema) and an anaphylactic (allergic) reaction; infections including serious and fatal bacterial, fungal, and new or reactivated viral infections and reduction in immunoglobulins.

TG Therapeutics is a biopharmaceutical company focused on the acquisition, development, and commercialization of novel treatments for B-cell diseases. To learn more, visit briumvi.com or tgtherapeutics.com.

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