FDA Approves TG Therapeutics’ Briumvi for Multiple Sclerosis

The FDA has approved TG Therapeutics’ Briumvi (ublituximab-xiiy) for treatment of relapsing forms of multiple sclerosis — including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.

The monoclonal antibody treatment is administered in a four-hour infusion on the first day of therapy, followed by a one-hour infusion 15 days later, and then every 24 weeks.

The agency approval was based on results from two phase 3 clinical trials, with Briumvi demonstrating superiority over teriflunomide in reducing the annualized relapse rate, and the number of new or enlarging lesions.

The company plans on launching the drug in the first quarter of 2023.