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FDA Approves Briumvi™ (ublituximab-xiiy) for Relapsing MS

December 28, 2022

Announced price is lower than many other MS therapies

  • The U.S. Food and Drug Administration has approved Briumvi (ublituximab-xiiy, TG Therapeutics) as an infused (given through a needle placed in a vein) disease-modifying therapy for adults with relapsing forms of MS.
  • Relapsing forms of MS include clinically isolated syndrome (an initial neurological episode), relapsing-remitting MS, and active secondary progressive MS. People with active secondary progressive MS have had progression of disability but still experience acute relapses or new MRI activity.
  • Briumvi is a monoclonal antibody that binds to a molecule (CD20) on the surface of immune cells called B cells and depletes (removes) them from circulation. This mode of action is similar to Ocrevus® (ocrelizumab, Genentech, Inc.) and Kesimpta® (ofatumumab, Novartis). B cells have several functions including making antibodies, and evidence suggests they play a role in immune-system mediated damage to the brain and spinal cord in MS.
  • Briumvi is administered as a 1-hour intravenous (IV) infusion every 24 weeks after an initial round of two infusions two weeks apart.
  • In published results of two phase 3 clinical trials (ULTIMATE I and II), Briumvi significantly reduced relapse rates and MRI-detected new and/or enlarging brain lesions more than oral teriflunomide (Aubagio®, Sanofi Genzyme) over 96 weeks. The percentage of participants with worsening of disability was similar in both treatment groups.
  • Side Effects: The most common adverse reactions reported from clinical trials were infusion related reactions, such as fever, chills, and flu-like symptoms, and upper respiratory tract infections. Briumvi may cause serious side effects (see below under Potential Risks).
  • Availability: TG Therapeutics has announced that Briumvi should be available for prescription by February 2023.
  • Support Programs: The company has announced its intent to enable access to Briumvi through support programs. For more information, individuals may call: 1-833-briumvi (274-8684) or visit
  • Price: TG Therapeutics has announced that Briumvi will have an initial annual list price of $59,000. This price is for the medicine alone for two infusions a year. Infused therapies also carry medical costs for getting the infusion administered. The actual cost to an individual will depend on the provisions of their insurance coverage and the degree to which that individual will be eligible for programs designed to assist with out-of-pocket costs.
“We are pleased there is a new high-efficacy* treatment option approved for relapsing MS. For a complex disease like MS, having additional treatment options for people to consider is incredibly important,” said Bari Talente, Executive Vice President, Advocacy & Healthcare Access at the National MS Society. “We also applaud TG Therapeutics for pricing Briumvi significantly lower than other MS therapies, helping to increase access and enable more people with MS to potentially benefit from this new therapy.”
(*High-efficacy MS treatments include: natalizumab (Tysabri®), alemtuzumab (Lemtrada®), ocrelizumab (Ocrevus®), rituximab (Rituxan®), ofatumumab (Kesimpta®) and Autologous Hematopoietic Stem Cell Transplantation (aHSCT). Some MS specialists consider cladribine (Mavenclad®) in this group. Read more about disease-modifying therapies and other treatments for MS and MS symptoms.
Download prescribing information for Briumvi (.pdf).
Download the Briumvi Medication Guide for patients (.pdf)
About Briumvi: Briumvi (bree-um’-vee)  is a monoclonal antibody that binds to a molecule (CD20) on the surface of immune cells called B cells and removes them from circulation. Similar therapies are approved by the FDA to treat MS: Ocrevus (ocrelizumab) and Kesimpta (ofatumumab). B cells have several functions including making antibodies, and evidence suggests they play a role in immune-system mediated damage to the brain and spinal cord in MS.
Potential Risks: Prescribing information cautions that Briumvi should not be administered in individuals with active infection, and live or live-attenuated vaccines are not recommended during treatment and after discontinuing treatment until B cells return. Because Briumvi reduces B cells that make immunoglobulins to help fight infections, levels should be monitored before, during, and after treatment. Because of the risk for fetal harm, women are cautioned to use birth control during and for 6 months after stopping Briumvi.
PML (progressive multifocal leukoencephalopathy) is a rare, serious brain infection that can result in death or severe disability. Although no cases of PML 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. Individuals are cautioned to tell their healthcare providers if experiencing any new or worsening neurological symptoms such as weakness on one side of the body, loss of coordination in arms and legs, vision problems, changes in thinking and memory, or confusion and personality changes.
Pre-dosing Tests and Dosing: Individuals prescribed Briumvi are required to have blood tests to screen for the presence of Hepatitis B virus (HBV), and for serum levels of immunoglobulins. Before treatment with Briumvi, individuals will receive a corticosteroid and an antihistamine medicine to help reduce the risk of infusion reactions by making them less frequent and less severe. When starting Briumvi, individuals will receive two infusions two weeks apart, and thereafter will receive Briumvi every 24 weeks.
Taking a disease-modifying therapy is currently the best way to reduce MS disease activity, prevent accumulation of disability and protect the brain from damage due to MS. Selecting an MS therapy should be done by people with MS in collaboration with their MS healthcare provider. Important questions to be considered and discussed with your doctor in terms of Briumvi include:
Starting a disease-modifying therapy during the COVID-19 pandemic: There is some evidence that disease modifying therapies that work in a similar way as Briumvi may increase the chance of having a more severe form of COVID-19, including a greater risk for hospitalization. People who lack B cells, such as those on B cell depleting therapies, may have reduced or even absent antibody responses to vaccines, though other aspects of their vaccine response (T cells) are likely to be increased. Review our vaccine timing considerations, and work with your MS healthcare provider to determine the best time to get your additional dose or booster.

These therapies should still be considered as an option for treating MS during the pandemic. People with MS who are taking them should take precautions to reduce their risk of infection including staying up-to-date with COVID-19 vaccines and discussing with your healthcare provider if Briumvi is right for you. If people with MS taking these types of therapy test positive for COVID-19, they should contact their healthcare provider as soon as possible to discuss potential treatment options.

Aubagio is a registered trademark of Sanofi Genzyme
Briumvi is a registered trademark of TG Therapeutics
Kesimpta is a registered trademark of Novartis
Ocrevus is a registered trademark of Genentech, Inc.

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Multiple sclerosis is an unpredictable disease of the central nervous system. Currently there is no cure. Symptoms vary from person to person and may include disabling fatigue, mobility challenges, cognitive changes, and vision issues. An estimated 1 million people live with MS in the United States. Early diagnosis and treatment are critical to minimize disability. Significant progress is being made to achieve a world free of MS.

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