TG Therapeutics obtains FDA OK for Briumvi
TG Therapeutics received the Food and Drug Administration's blessing for Briumvi (ublituximab-xiiy), for the treatment of relapsing forms of multiple sclerosis, including 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 noted. The administration schedule of Briumvi consists of a day one infusion of 150 mg administered in four hours, a day 15 infusion of 450 mg administered in one hour, followed by 450 mg infusions every 24 weeks administered in one hour, the company said.
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“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,” said Michael Weiss, the company's chairman and CEO. “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,” said Weiss.
“Over the past several years we have seen a dramatic shift in the MS treatment landscape towards the use of B-cell therapy, which has shown to be highly effective in reducing relapses in patients. The outcome of the ULTIMATE I & II trials evaluating ublituximab, a novel targeted anti-CD20 agent designed for efficient B-cell depletion that supported this approval, represents an important milestone in the history of MS research as the first Phase 3 study of an anti-CD20 monoclonal antibody in patients with relapsing MS to produce an annualized relapse rate of less than 0.10, which translates to less than 1 relapse in 10 years,” said Lawrence Steinman, Zimmermann professor of neurology and neurological sciences, and pediatrics at Stanford University. “This approval is great news for patients living with MS and provides an appealing treatment alternative that can be administered in a one-hour infusion twice a year following the starting dose, which I believe is an added benefit to patients.”
“We are pleased to have a new treatment approved for people with relapsing forms of Multiple Sclerosis. MS is an unpredictable disease of the central nervous system that affects each person differently. Since we know that early treatment can minimize disease progression, it is incredibly important for people with MS to have a choice of treatment options to find the one that works best for them,” said Bari Talente, executive vice president, advocacy and healthcare access at the National MS Society.
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“The approval of Briumvi is wonderful news. MS is most frequently diagnosed during the prime of a person’s life when they are just starting a career or beginning a family. The availability of anti-CD20s has launched a new era of high efficacy therapies for multiple sclerosis,” said June Halper, CEO of the Consortium of Multiple Sclerosis Centers. “The addition of Briumvi has added to the hope chest of patients, families, and the MS professional community. As a multi-disciplinary organization centered on the needs of those with MS, we appreciate the increasing array of treatment choices. Congratulations to TG Therapeutics from the CMSC and our leadership.”