FDA Approval: TG Therapeutics’ Breakthrough for Multiple Sclerosis

A Therapy That Fits Into a Lunch Break

Imagine treating multiple sclerosis with just a one-hour IV infusion twice a year—a therapy so convenient yet powerful that it can dramatically cut relapse rates. In late 2022, this became a reality when TG Therapeutics’ new drug Briumvi (ublituximab-xiiy) earned FDA approval¹. Briumvi is a laboratory-engineered antibody that targets immune cells known to drive MS. Its approval marks a promising new chapter in MS care, offering high efficacy with a shorter and easier dosing schedule than many existing therapies.

Why This Approval Could Reshape MS Treatment

Multiple sclerosis (MS) is a chronic immune-mediated symptom in which the body attacks the protective coating of nerves, resulting in symptoms from fatigue and mobility limitations to cognitive disruptions. It often begins in early adulthood—just as many are establishing careers and families. While more than 20 FDA-approved disease-modifying therapies (DMTs) exist, many come with trade-offs: frequent dosing, long infusion times, or immune-related side effects².

The FDA’s December 28, 2022 approval of Briumvi signaled a major step forward¹. It became the third anti-CD20 therapy approved for MS, following Ocrevus (ocrelizumab) and Kesimpta (ofatumumab). However, Briumvi is the first and only one that can be infused in just one hour for maintenance doses³.“The approval of Briumvi is wonderful news,” said June Halper, CEO of the Consortium of MS Centers, emphasizing its importance for people diagnosed during the most active years of life.

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The Trade-Offs Patients Still Face

Despite scientific progress, MS users still face major hurdles:

• Convenience vs. efficacy: Powerful therapies like Ocrevus require 3- to 4-hour infusions twice a year⁵, while others like Kesimpta demand monthly self-injections.
• Safety and tolerability: Immune suppression increases the risk of infections and infusion reactions.
• Cost and complexity: Treatment costs can be staggering—some exceeding $70,000/year—placing pressure on both users and health systems⁶.

Briumvi’s one-hour infusion format was designed to reduce this burden while maintaining high effectiveness³.

How Briumvi Works on the Cellular Level

Research has shown that certain B-cells—immune cells marked by the CD20 protein—play a key role in MS inflammation. These cells interact with T-cells, encouraging them to attack myelin, the protective sheath around nerves⁷.

Briumvi is a CD20-directed monoclonal antibody, meaning it binds to CD20 on these harmful B-cells and flags them for destruction. What makes Briumvi unique is that it’s glycoengineered to improve the body’s natural ability to eliminate these cells via antibody-dependent cellular cytotoxicity⁸.Compared to older CD20 therapies, Briumvi offers a smaller dose (450 mg) and a quicker infusion time, without compromising immune modulation.

What the Data Tells Us About Briumvi’s Performance

Briumvi’s FDA approval was based on two Phase 3 studies—ULTIMATE I and II—which enrolled 1,094 participants with relapsing MS¹⁰. These were double-blind, double-dummy trials comparing Briumvi to teriflunomide (Aubagio) over 96 weeks.

Key findings:

• Annualized Relapse Rate (ARR):
  • ULTIMATE I: 0.08 relapses/year (Briumvi) vs. 0.19 (teriflunomide)
  • ULTIMATE II: 0.09 vs. 0.18
    This represents a 50–60% reduction in relapse frequency¹⁰.
• MRI Brain Lesions:
  Briumvi users had nearly zero new gadolinium-enhancing lesions on MRI, compared to roughly 0.5 in the teriflunomide group—a ~95% reduction in new brain inflammation¹¹.
• No Evidence of Disease Activity (NEDA):
  • ULTIMATE I: 44.6% achieved NEDA vs. 15%
  • ULTIMATE II: 43% vs. 11.4%
    Achieving NEDA is the gold standard in MS care¹².
• Disability Progression:
  There was no significant difference in disability worsening between groups (5.2% vs. 5.9%), though more Briumvi users showed signs of disability improvement¹³.
• Safety:
  The most common side effects were infusion-related reactions (47.7%), typically mild to moderate. Pre-treatment with steroids and antihistamines helped manage these events¹³.
  Serious infections occurred in 5.0% of Briumvi users vs. 2.9% on teriflunomide¹³.
  Importantly, no cases of PML (a rare brain infection) occurred in either group¹⁴.

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What This Means in the Real World

For many, Briumvi’s shorter infusion time could be life-changing. A one-hour biannual appointment, rather than a multi-hour infusion or monthly injection, could free up dozens of hours per year. It’s a meaningful shift for parents, professionals, and caregivers trying to balance treatment with life demands⁵.

Clinics also benefit: shorter infusions increase patient throughput and lower costs. Briumvi’s list price—$59,000/year—is notably lower than competitors like Ocrevus, which lists at around $71,000/year⁶.

“For those who dislike injections or have limited time for infusions, this new DMT is worth discussing with your neurologist,” wrote MS columnist Ed Tobias¹⁵.

What to Ask Your Health Professional

If you or someone you know lives with relapsing MS, ask your health professional whether Briumvi could be an option. For more, visit the FDA’s approval summary or explore support resources from the National MS Society.

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Fußnoten

1. U.S. Food & Drug Administration. “FDA Approves Briumvi for Relapsing Forms of Multiple Sclerosis.” Dec 28, 2022. FDA.gov. 
2. National MS Society. “Disease-Modifying Therapies for MS.” NationalMSSociety.org.
3. TG Therapeutics. “Briumvi: A New Anti-CD20 Therapy with 1-Hour Infusion.” TGtherapeutics.com.
4. Consortium of MS Centers. Press Statement, Jan 2023.
5. Rocky Mountain MS Center. “MS Drug Comparison Chart,” 2023.
6. ICER. “Pricing Assessment of Disease-Modifying Therapies for MS.” 2023.
7. Hauser SL et al. “B-Cell Depletion in the Treatment of Multiple Sclerosis.” NEJM, 2008.
8. Fox EJ et al. “Mechanism of Action of Ublituximab in MS.” Neurology, 2022.
9. TG Therapeutics Product Label for Briumvi. TGtherapeutics.com.
10. Steinman L, et al. “Ublituximab versus Teriflunomide in Relapsing MS.” New England Journal of Medicine, 2022; 387:704–714.
11. Ibid., Supplemental Appendix, MRI Outcomes.
12. Steinman L et al. NEDA Outcomes in ULTIMATE Trials. NEJM, 2022.
13. FDA Advisory Committee Briefing Document. December 2022.
14. ClinicalTrials.gov. “ULTIMATE I and II Long-Term Safety Extension.” ClinicalTrials.gov.
15. Tobias E. “Briumvi’s Approval is a Big Deal for MS.” Multiple Sclerosis News Today, Jan 2023.