FDA Approves Briumvi to Treat Relapsing Multiple Sclerosis

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On December 28, 2022, the U.S. Food and Drug Administration (FDA) approved Briumvi (ublituximab) , a disease-modifying therapy (DMT) to treat relapsing forms of multiple sclerosis (RMS) in adults, including clinically isolated syndrome, relapsing-remitting MS, and active secondary-progressive MS. An estimated one million people in the United States live with MS, with about 25,000 new people diagnosed each year, according to the National MS Society . Briumvi, manufactured by TG Therapeutics, is a glycoengineered monoclonal antibody designed to target B cells — a type of white blood cell — and reduce their numbers. These cells are thought to be one of the immune cells that attacks myelin — the protective coating that insulates nerve cells — in people with MS. Glycoengineered means removing certain sugar molecules normally expressed on the antibody, which is thought to enhance potency of the drug. “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,” said Lawrence Steinman, MD , global study leader for the ULTIMATE 1 and 2 trials and professor of neurology and neurological sciences at Stanford Medicine in Palo Alto, California, in a press release . These trials are an important milestone in MS research: For the first time, an anti-CD20 monoclonal antibody was able to produce an annualized relapse rate (ARR) of less than 0.10 in patients with relapsing MS, which translates to less than one relapse in 10 years, said Dr. Steinman. “The approval of Briumvi is wonderful news,” said June Halper , CEO of the Consortium of Multiple Sclerosis Centers, also in the press release. “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.” Briumvi Offers Shorter Infusion Time Compared With Other Anti-CD20 Drugs Briumvi is the third anti-CD20 MS medication the FDA has approved, joining ocrelizumab (Ocrevus) and ofatumumab (Kesimpta) . Briumvi has a similar mechanism of action to Ocrevus and Kesimpta, but it hits a slightly different target, says Daniel Ontaneda, MD, PhD , a physician at the Mellen Center for MS at Cleveland Clinic. Dr. Ontaneda was not involved in the trials. “One key advantage over other infusion medications is that it can be given quicker with a shorter infusion time,” Ontaneda says. The drug is the first B-cell therapy for use in people with RMS that can be given as a one-hour IV infusion every six months, following the first dose. Ocrevus is given as a 2.5-hour IV infusion every six months, and Kesimpta requires an infusion each month. Clinical Trials Compared Briumvi With Aubagio The FDA approval of Briumvi is based on the findings from two identical, randomized, double-blind, active-controlled phase 3 trials, ULTIMATE 1 and ULTIMATE 2. These studies compared the efficacy and safety of Briumvi with teriflunomide (Aubagio) , a once-daily oral DMT for people with relapsing forms of MS. Participants were randomly assigned to receive either 150 milligrams (mg) of Briumvi via IV infusion on Day 1, 450 mg on Day 15, and then a 450-mg dose every six months; or 14 mg of Aubagio orally once daily. The results, published on August 25, 2022, in The New England Journal of Medicine , showed that treatment with Briumvi showed a statistically significant reduction in annualized relapse rate (ARR) over a 96-week period compared with Aubagio. In ULTIMATE 1, treatment with Briumvi resulted in an ARR of 0.076 versus 0.188 for Aubagio, representing a relative reduction of approximately 60 percent, or less than one relapse for every 13 patient-years. In ULTIMATE 2, treatment with Briumvi resulted in an ARR of 0.091 versus 0.178 for Aubagio, representing a relative reduction of approximately 50 percent, or less than one relapse for every 11 patient-years. Study data also showed a significant improvement in the “no evidence of disease activity” (NEDA) markers. In the studies, NEDA was observed in 44.6 percent and 43 percent of Briumvi-treated patients and in 15 percent and 11.4 percent of the Aubagio treated patients in ULTIMATE 1 and ULTIMATE 2, respectively. Safety Profile of Briumvi Infusion-related reactions were the most common adverse event associated with Briumvi. “Although common — about 50 percent of patients experienced an infusion-related reaction — they were mostly mild or moderate and rarely resulted in treatment discontinuation. This is similar to other anti-CD20 medications such as ocrelizumab,” says Ontaneda. Infusion-related reactions can include fever, chills, headache, influenza-like illness, rapid heartbeat (tachycardia), nausea, throat irritation, erythema, and an anaphylactic reaction . How Much Will Briumvi Cost? “Having now three choices for a monoclonal antibody in this class provides the individual with MS and their physician, a ‘menu’ of choices. It may also help improve the economics when there is competition,” says Steinman. Before discounts, Briumvi will cost $59,000 a year, making it the lowest-priced branded DMT approved for people with MS, according to a company presentation. For comparison, the annual list price of Ocrevus is $68,121.64 a year. This price is for the medicine alone; infused therapies such as Briumvi also carry medical costs for the infusion process. Because of the competitive pricing and the efficacy shown in the clinical trials, the company said they expect positive early coverage decisions by many insurance plans. The company has also announced its intent to enable access to Briumvi through support programs that begin enrollment on January 9, 2023. For more information, individuals may also call 833-BRIUMVI (833-274-8684). Briumvi should be available for prescription by February 2023, according to the company.

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