The new therapy will be the lowest-cost branded DMT approved for people with RMS.
By Becky Upham
December 29, 2022
Briumvi can be given as a one-hour infusion every six months.
The disease-modifying treatment (DMT) Briumvi (ublituximab), used to treat individuals with relapsing types of multiple sclerosis (RMS), such as clinically isolated MS, relapsing-remitting MS, and active secondary-progressive MS, received FDA approval on December 28, 2022.
According to the National MS Society, there are roughly 25,000 newly diagnosed cases of MS each year in the United States, where an estimated one million people have the disease.
A glycoengineered monoclonal antibody called Briumvi, produced by TG Therapeutics, is intended to target and suppress the growth of B cells, a subset of white blood cells. The immune cells that assault the myelin, the covering that insulates nerve cells, in MS patients are likely to be one of these cells.
Glycoengineered refers to the removal of specific sugar molecules that are typically expressed on the antibody, which is supposed to increase the drug's potency.
According to a press release from Stanford Medicine in Palo Alto, California, where Dr. Lawrence Steinman is a professor of neurology and neurological sciences, "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."
These trials represent a significant turning point in MS research: Dr. Steinman reported that individuals with relapsing MS experienced an annualized relapse rate (ARR) of less than 0.10 for the first time, which equates to less than one relapse per ten years.
June Halper, CEO of the Consortium of Multiple Sclerosis Centers, noted in the press release that the approval of Briumvi was "great news." The prime of a person's life, when they are just starting a profession or starting a family, is when MS is most usually discovered. Anti-CD20s are now widely available, ushering in a new age of highly effective treatments for multiple sclerosis.
Briumvi Offers Shorter Infusion Time Compared With Other Anti-CD20 Drugs
Ocrelizumab (Ocrevus) and ofatumumab are the other two anti-CD20 MS medications that the FDA has approved. Briumvi is the third (Kesimpta).
According to Daniel Ontaneda, MD, PhD, a clinician at the Cleveland Clinic's Mellen Center for MS, Briumvi has a similar mechanism of action to Ocrevus and Kesimpta but strikes a slightly different target. The experiments did not involve Dr. Ontaneda. According to Ontaneda, "a major advantage over other infusion drugs is that it can be given more quickly with a shorter infusion time."
The medication is the first B-cell treatment for RMS patients that can be administered as a one-hour IV infusion every six months after the initial dosage. Kesimpta needs an IV infusion every month, and Ocrevus requires a 2.5-hour IV infusion every six months.
Clinical Trials Compared Briumvi With Aubagio
The results of the identical ULTIMATE 1 and ULTIMATE 2 phase 3 randomized, double-blind, active-controlled studies served as the foundation for the FDA's approval of Briumvi. In these studies, the effectiveness and safety of Briumvi were compared to those of teriflunomide (Aubagio), an oral DMT given once daily to patients with relapsing forms of MS.
Participants were given either 14 mg of Aubagio or 150 milligrams (mg) of Briumvi intravenously (IV) once on Day 1, 450 mg on Day 15, and subsequently 450 mg every six months.
Results were evaluated between Briumvi and Aubagio over a 96-week period and were published on August 25, 2022 in The New England Journal of Medicine. Briumvi treatment resulted in a statistically significant decrease in annualized relapse rate (ARR).
An ARR of 0.076 for Briumvi therapy in ULTIMATE 1 compared to 0.188 for Aubagio resulted in a relative reduction of around 60%, or less than one relapse for every 13 patient-years.
Treatment with Briumvi led to an ARR of 0.091 against 0.178 for Aubagio in ULTIMATE 2, which is less than one relapse for every 11 patient-years and a relative reduction of about 50%.
The "no evidence of disease activity" (NEDA) indicators significantly improved, according to study results.
In the studies, NEDA was noted in 44.6% and 43.6% of patients receiving Briumvi treatment and in 15% and 11.4% of patients receiving Aubagio treatment in ULTIMATE 1 and ULTIMATE 2, respectively.
Safety Profile Of Briumvi
The most frequent adverse event linked to Briumvi was infusion-related responses. "Although infusion-related reactions were common—about 50% of individuals did—they were often mild or moderate, and treatment discontinuation was infrequently the result. According to Ontaneda, this is comparable to other anti-CD20 drugs like ocrelizumab.
Fever, chills, headache, influenza-like illness, tachycardia, nausea, sore throat, erythema, and anaphylactic reactions are just a few of the events that might result from an infusion.
How Much Will Briumvi Cost?
"Having three options for monoclonal antibodies in this class now gives people with MS and their doctors a "menu" of options. When there is competition, it might also boost the economy, according to Steinman.
According to a corporate presentation, Briumvi will cost $59,000 per year before discounts, making it the least expensive branded DMT authorized for MS patients. Ocrevus' list price is $68,121.64 per year, for reference.
This cost just applies to the medication; injected medicines like Briumvi also have associated medical expenses related to the infusion procedure.
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 business has also declared its intention to make Briumvi accessible through support initiatives that open for enrollment on January 9, 2023. Individuals can also call 833-BRIUMVI for further details (833-274-8684).
By February 2023, Briumvi should be prescribedable, according to the company.
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