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Briumvi (ublituximab) Approved by FDA for Relapsing MS

The U.S. Food and Drug Administration has approved Briumvi (ublituximab) as a disease-modifying therapy for adults with relapsing forms of MS.  And as of late January, this DMT is now commercially available for use in the United States.

Briumvi is an infused therapy and is approved for individuals with clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.  The infusion is about one hour. Briumvi is a monoclonal antibody that binds to a CD20 molecule on B cells and depletes them from circulation. This mechanism of action is similar to Ocrevus (ocrelizumab), Rituxan (rituximab), and Kesimpta (ofatumumab).  Briumvi is administered via an hour-long intravenous infusion every 24 weeks after an initial two infusions two weeks apart.

In two Phase 3 clinical trials (ULTIMATE I and II), Briumvi significantly reduced relapse rates and new and/or enlarging brain lesions more than teriflunomide (Aubagio) over 96 weeks.  The percentage of participants with worsening of disability was similar in both treatment groups. There was no greater reduction in confirmed disability progression at 12 weeks compared to Aubagio (teriflunomide), perhaps because disability progression was low overall in both groups. Notably, the Phase III trials were primarily done in Eastern Europe, so generalizability to African-American or Hispanic populations is unclear.

Knowledge about MS has grown tremendously in the last few decades and this has led to the development of disease modifying therapies.  The first DMTs were introduced in the early 1990s, and there are now 24 FDA-approved DMTs in use – adding to our arsenal of treatment tools. We encourage patients to be informed about their condition and all treatment options. Patients should always consult their own physician before commencing any course of treatment.

In the clinical trials of Briumvi, the most common side effects were infusion related reactions including fever, chills, and flu-like symptoms, and upper respiratory tract infections. Briumvi should not be administered in individuals with active infection. Live or live-attenuated vaccines are not recommended during treatment and after discontinuing treatment until B cells return. B Cell levels should be monitored before, during, and after treatment. Due to the risk for fetal harm, women are cautioned to use birth control during and for 6 months after stopping Briumvi.

Although no cases of PML (Progressive Multifocal Leukoencephalopathy) have occurred in MS patients treated with Briumvi, JCV infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies. PML is a rare but serious brain infection that is caused by the JC Virus (JCV). PML is seen in MS patients who are JC virus (JCV) positive and on disease modifying therapies known to increase the risk of PML.

TG Therapeutics, the manufacturer of this DMT, has announced that Briumvi is now available for prescription as of late January, 2023.  The cost of this drug is $59,000 per year, and infusion costs may be less due to shorter infusion time. The company has established a patient support program to help patients access the DMT.  For more information, individuals may call: 1-833-briumvi (274-8684) or visit www.briumvipatientsupport.com.

For more information about disease modifying therapies, please the MS Center’s complete listing of approved MS drugs in common use here:  https://mscenter.org/treating-ms/medications/

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