Motor neuron connecting to muscle fiber to illustrate myasthenia gravis
Credit: Dr_Microbe/Getty Images

TG Therapeutics, scored a win this week, announcing the U.S. Food and Drug Administration (FDA) approved BRIUMVI (ublituximab-xiiy), for the treatment of relapsing forms of multiple sclerosis (MS). While the drug enters a market that is crowded, it is a growing one—MS therapeutics are worth over $25 billion now, and expected to net almost $34 billion by 2030.

BRIUMVI is the first anti-CD20 monoclonal antibody approved for patients with relapsing MS that can be administered in a one-hour infusion following the starting dose, which requires four hours. Indications include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Multiple sclerosis affects about one million people in the United States and 2.3 million people globally, according to the National Multiple Sclerosis Society.

Michael S. Weiss, TG’s Chairman and Chief Executive Officer, said, “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.”

Approval was granted based on data from two phase III trials—the ULTIMATE I & II. These demonstrated BRIUMVI’s superiority over teriflunomide in significantly reducing the annualized relapse rate (ARR), the number of T1 Gd-enhancing lesions, and the number of new or enlarging T2 lesions. Results from these trials were published in August this year in The New England Journal of Medicine. 

ULTIMATE I & II were two randomized trials of identical design, in patients with RMS treated for 96 weeks. Patients received either BRIUMVI, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour. Oral placebo was administered daily, or teriflunomide, the active comparator, was given orally as a 14 mg daily dose with IV placebo administered on the same schedule as BRIUMVI.

Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University, stated, “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.”

He added that, “… [This is] the first Phase III 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 one relapse in 10 years. 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.”

June Halper, MSN, APN-C, MSCN, FAAN, Chief Executive Officer of the Consortium of Multiple Sclerosis Centers said, “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. The addition of BRIUMVI has added to the hope chest of patients, families, and the MS professional community.”

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