TG Therapeutics announces FDA approval of Briumvi

TG Therapeutics announced the U.S. Food and Drug Administration has approved Briumvi for the treatment of relapsing forms of multiple sclerosis, or RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Briumvi is "the first and only anti-CD20 monoclonal antibody approved for patients with RMS that can be administered in a one-hour infusion following the starting dose," the company stated. Michael Weiss, the company’s Chairman and CEO, stated, "Today’s FDA approval marks an exciting day for everyone touched by MS and everyone that has worked on the development of Briumvi. We believe in the importance of treatment alternatives for patients and believe the profile of Briumvi offers unique attributes to patients and physicians alike. We have built a strong commercial team with deep knowledge of the MS landscape and look forward to launching in Q1 2023. We want to thank the patients and their families, the clinical investigators and their teams, and our advisors for their support and participation in our trials, and for helping us get to this point. We remain committed to the patients we serve and providing seamless access to Briumvi once launched."