{"id":2465,"date":"2025-05-28T07:00:00","date_gmt":"2025-05-28T07:00:00","guid":{"rendered":"https:\/\/healthscience.institute\/?p=2465"},"modified":"2025-12-09T08:49:58","modified_gmt":"2025-12-09T08:49:58","slug":"fda-approval-multiple-sclerosis-therapy","status":"publish","type":"post","link":"https:\/\/staging.scienceinhealth.com\/es\/fda-approval-multiple-sclerosis-therapy\/","title":{"rendered":"FDA Approval: TG Therapeutics&#8217; Breakthrough for Multiple Sclerosis"},"content":{"rendered":"<h2 class=\"wp-block-heading\"><strong>A Therapy That Fits Into a Lunch Break<\/strong><\/h2>\n\n\n\n<p>Imagine treating multiple sclerosis with just a one-hour IV infusion twice a year\u2014a therapy so convenient yet powerful that it can dramatically cut relapse rates. In late 2022, this became a reality when TG Therapeutics\u2019 new drug Briumvi (ublituximab-xiiy) earned FDA approval<sup>1<\/sup>. 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.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Why This Approval Could Reshape MS Treatment<\/strong><\/h2>\n\n\n\n<p>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\u2014just 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 effects<sup>2<\/sup>.<\/p>\n\n\n\n<p>The FDA\u2019s December 28, 2022 approval of Briumvi signaled a major step forward<sup>1<\/sup>. 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 doses<sup>3<\/sup>.\u201cThe approval of Briumvi is wonderful news,\u201d said June Halper, CEO of the Consortium of MS Centers, emphasizing its importance for people diagnosed during the most active years of life.<\/p>\n\n\n\n<p><strong><a href=\"http:\/\/scienceinhealth.com\/newsletter\/\">Suscr\u00edbase gratis para obtener art\u00edculos de salud m\u00e1s perspicaces adaptados a sus necesidades.<\/a><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>The Trade-Offs Patients Still Face<\/strong><\/h2>\n\n\n\n<p>Despite scientific progress, MS users still face major hurdles:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Convenience vs. efficacy:<\/strong> Powerful therapies like Ocrevus require 3- to 4-hour infusions twice a year<sup>5<\/sup>, while others like Kesimpta demand monthly self-injections.<\/li>\n\n\n\n<li><strong>Safety and tolerability:<\/strong> Immune suppression increases the risk of infections and infusion reactions.<\/li>\n\n\n\n<li><strong>Cost and complexity:<\/strong> Treatment costs can be staggering\u2014some exceeding $70,000\/year\u2014placing pressure on both users and health systems<sup>6<\/sup>.<\/li>\n<\/ul>\n\n\n\n<p>Briumvi\u2019s one-hour infusion format was designed to reduce this burden while maintaining high effectiveness<sup>3<\/sup>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>How Briumvi Works on the Cellular Level<\/strong><\/h2>\n\n\n\n<p>Research has shown that certain B-cells\u2014immune cells marked by the <strong>CD20 protein<\/strong>\u2014play a key role in MS inflammation. These cells interact with T-cells, encouraging them to attack myelin, the protective sheath around nerves<sup>7<\/sup>.<\/p>\n\n\n\n<p>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\u2019s glycoengineered to improve the body\u2019s natural ability to eliminate these cells via antibody-dependent cellular cytotoxicity<sup>8<\/sup>.Compared to older CD20 therapies, Briumvi offers a smaller dose (450 mg) and a quicker infusion time, without compromising immune modulation.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>What the Data Tells Us About Briumvi\u2019s Performance<\/strong><\/h2>\n\n\n\n<p>Briumvi\u2019s FDA approval was based on two Phase 3 studies\u2014ULTIMATE I and II\u2014which enrolled 1,094 participants with relapsing MS<sup>10<\/sup>. These were double-blind, double-dummy trials comparing Briumvi to teriflunomide (Aubagio) over 96 weeks.<\/p>\n\n\n\n<p>Key findings:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Annualized Relapse Rate (ARR):<\/strong>\n<ul class=\"wp-block-list\">\n<li>ULTIMATE I: 0.08 relapses\/year (Briumvi) vs. 0.19 (teriflunomide)<\/li>\n\n\n\n<li>ULTIMATE II: 0.09 vs. 0.18<strong><br><\/strong> This represents a 50\u201360% reduction in relapse frequency<sup>10<\/sup>.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>MRI Brain Lesions:<br><\/strong> Briumvi users had nearly zero new gadolinium-enhancing lesions on MRI, compared to roughly 0.5 in the teriflunomide group\u2014a ~95% reduction in new brain inflammation<sup>11<\/sup>.<\/li>\n\n\n\n<li><strong>No Evidence of Disease Activity (NEDA):<\/strong>\n<ul class=\"wp-block-list\">\n<li>ULTIMATE I: 44.6% achieved NEDA vs. <strong>15%<\/strong><\/li>\n\n\n\n<li>ULTIMATE II: 43% vs. 11.4%<br> Achieving NEDA is the gold standard in MS care<sup>12<\/sup>.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Disability Progression:<br><\/strong> There was no significant difference in disability worsening between groups (5.2% vs. 5.9%), though more Briumvi users showed signs of disability improvement<sup>13<\/sup>.<\/li>\n\n\n\n<li><strong>Safety<\/strong>: <br>The most common side effects were infusion-related reactions (47.7%), typically mild to moderate. Pre-treatment with steroids and antihistamines helped manage these events<sup>13<\/sup>.<br>Serious infections occurred in 5.0% of Briumvi users vs. 2.9% on teriflunomide<sup>13<\/sup>.<br>Importantly, no cases of PML (a rare brain infection) occurred in either group<sup>14<\/sup>.<\/li>\n<\/ul>\n\n\n\n<p><strong><a href=\"http:\/\/scienceinhealth.com\/newsletter\/\">Suscr\u00edbase gratis para obtener art\u00edculos de salud m\u00e1s perspicaces adaptados a sus necesidades.<\/a><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>What This Means in the Real World<\/strong><\/h2>\n\n\n\n<p>For many, Briumvi\u2019s 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\u2019s a meaningful shift for parents, professionals, and caregivers trying to balance treatment with life demands<sup>5<\/sup>.<\/p>\n\n\n\n<p>Clinics also benefit: shorter infusions increase patient throughput and lower costs. Briumvi\u2019s list price\u2014$59,000\/year\u2014is notably lower than competitors like Ocrevus, which lists at around $71,000\/year<sup>6<\/sup>.<\/p>\n\n\n\n<p><em>\u201cFor those who dislike injections or have limited time for infusions, this new DMT is worth discussing with your neurologist,\u201d<\/em> wrote MS columnist Ed Tobias<sup>15<\/sup>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>What to Ask Your Health Professional<\/strong><\/h2>\n\n\n\n<p>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\u2019s approval summary or explore support resources from the<a href=\"https:\/\/www.nationalmssociety.org\/\"> National MS Society<\/a>.<\/p>\n\n\n\n<p><em>El art\u00edculo no constituye en modo alguno un consejo m\u00e9dico. Consulte con un profesional m\u00e9dico autorizado antes de iniciar cualquier tratamiento. Este sitio web puede recibir comisiones por los enlaces o productos mencionados en este art\u00edculo.<\/em><\/p>\n\n\n\n<p><strong><a href=\"http:\/\/scienceinhealth.com\/newsletter\/\">Suscr\u00edbase gratis para obtener art\u00edculos de salud m\u00e1s perspicaces adaptados a sus necesidades.<\/a><\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Notas a pie de p\u00e1gina<\/strong><\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li>U.S. Food &amp; Drug Administration. \u201cFDA Approves Briumvi for Relapsing Forms of Multiple Sclerosis.\u201d Dec 28, 2022.<a href=\"https:\/\/www.fda.gov\"> FDA.gov<\/a>.&nbsp;<\/li>\n\n\n\n<li>National MS Society. \u201cDisease-Modifying Therapies for MS.\u201d<a href=\"https:\/\/www.nationalmssociety.org\"> NationalMSSociety.org<\/a>.<\/li>\n\n\n\n<li>TG Therapeutics. \u201cBriumvi: A New Anti-CD20 Therapy with 1-Hour Infusion.\u201d<a href=\"https:\/\/www.tgtherapeutics.com\"> TGtherapeutics.com<\/a>.<\/li>\n\n\n\n<li>Consortium of MS Centers. Press Statement, Jan 2023.<\/li>\n\n\n\n<li>Rocky Mountain MS Center. \u201cMS Drug Comparison Chart,\u201d 2023.<\/li>\n\n\n\n<li>ICER. \u201cPricing Assessment of Disease-Modifying Therapies for MS.\u201d 2023.<\/li>\n\n\n\n<li>Hauser SL et al. \u201cB-Cell Depletion in the Treatment of Multiple Sclerosis.\u201d <em>NEJM<\/em>, 2008.<\/li>\n\n\n\n<li>Fox EJ et al. \u201cMechanism of Action of Ublituximab in MS.\u201d <em>Neurology<\/em>, 2022.<\/li>\n\n\n\n<li>TG Therapeutics Product Label for Briumvi.<a href=\"https:\/\/www.tgtherapeutics.com\"> TGtherapeutics.com<\/a>.<\/li>\n\n\n\n<li>Steinman L, et al. \u201cUblituximab versus Teriflunomide in Relapsing MS.\u201d <em>New England Journal of Medicine<\/em>, 2022; 387:704\u2013714. <\/li>\n\n\n\n<li>Ibid., Supplemental Appendix, MRI Outcomes.<\/li>\n\n\n\n<li>Steinman L et al. NEDA Outcomes in ULTIMATE Trials. NEJM, 2022.<\/li>\n\n\n\n<li>FDA Advisory Committee Briefing Document. December 2022.<\/li>\n\n\n\n<li>ClinicalTrials.gov. \u201cULTIMATE I and II Long-Term Safety Extension.\u201d<a href=\"https:\/\/clinicaltrials.gov\"> ClinicalTrials.gov<\/a>.<\/li>\n\n\n\n<li>Tobias E. \u201cBriumvi&#8217;s Approval is a Big Deal for MS.\u201d <em>Multiple Sclerosis News Today<\/em>, Jan 2023.\\Hauser, S.\u202fL., Waubant, E., Arnold, D.\u202fL., Vollmer, T., Antel, J., Fox, R.\u202fJ., \u2026 et al. (2008). B-cell depletion with rituximab in relapsing\u2013remitting multiple sclerosis. New England Journal of Medicine, 358, 676\u2013688. <a href=\"https:\/\/doi.org\/10.1056\/NEJMoa0706383\">https:\/\/doi.org\/10.1056\/NEJMoa0706383<\/a><\/li>\n\n\n\n<li>Steinman, L., Fox, E.\u202fJ., Hartung, H.-P., Alexander, J.\u202fS., Ortiz, G., Chambers, C., \u2026 Cree, B.\u202fA. (2022). Ublituximab versus teriflunomide in relapsing multiple sclerosis. New England Journal of Medicine, 387, 704\u2013714. <a href=\"https:\/\/doi.org\/10.1056\/NEJMoa2201904\">https:\/\/doi.org\/10.1056\/NEJMoa2201904<\/a><\/li>\n\n\n\n<li>Alvarez, E., Steinman, L., Fox, E.\u202fJ., Hartung, H.-P., Qian, P., Wray, S., \u2026 Cree, B.\u202fA. C. (2024). Improvements in no evidence of disease activity with ublituximab vs. teriflunomide in the ULTIMATE phase 3 studies in relapsing multiple sclerosis. Frontiers in Neurology, 15, Article 1473284. <a href=\"https:\/\/doi.org\/10.3389\/fneur.2024.1473284\">https:\/\/doi.org\/10.3389\/fneur.2024.1473284<\/a><\/li>\n\n\n\n<li>van Langelaar, J., Rijvers, L., Smolders, J., van Luijn, M.\u202fM., Kramer, M., Bending, D., \u2026 van Horssen, J. (2020). B and T cells driving multiple sclerosis: identity, mechanisms and potential triggers. Frontiers in Immunology, 11, Article 760. <a href=\"https:\/\/doi.org\/10.3389\/fimmu.2020.00760\">https:\/\/doi.org\/10.3389\/fimmu.2020.00760<\/a><\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"<p>A Therapy That Fits Into a Lunch Break Imagine treating multiple sclerosis with just a one-hour IV infusion twice&hellip;<\/p>","protected":false},"author":13,"featured_media":1694,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[22,18],"tags":[131,132,130],"class_list":["post-2465","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-digital-therapeutics","category-health-tech","tag-briumvi","tag-new-ms-treatment","tag-tg-therapeutics"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA Approves Briumvi: A Game-Changing MS Therapy - Health Science Institute<\/title>\n<meta name=\"description\" content=\"TG Therapeutics\u2019 Briumvi earns FDA approval for relapsing MS\u2014offering a one-hour infusion with powerful relapse reduction.\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Approves Briumvi: A Game-Changing MS Therapy - Health Science Institute\" \/>\n<meta property=\"og:description\" content=\"TG Therapeutics\u2019 Briumvi earns FDA approval for relapsing MS\u2014offering a one-hour infusion with powerful relapse reduction.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/staging.scienceinhealth.com\/es\/fda-approval-multiple-sclerosis-therapy\/\" \/>\n<meta property=\"og:site_name\" content=\"Health Science Institute\" \/>\n<meta property=\"article:published_time\" content=\"2025-05-28T07:00:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-12-09T08:49:58+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/staging.scienceinhealth.com\/wp-content\/uploads\/2025\/04\/TG-Therapeutics.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"768\" \/>\n\t<meta property=\"og:image:height\" content=\"512\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"author\" content=\"Dr Anne Therese Bernadette Laudato, MD\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Dr Anne Therese Bernadette Laudato, MD\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/staging.scienceinhealth.com\\\/fr\\\/fda-approval-multiple-sclerosis-therapy\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/staging.scienceinhealth.com\\\/fr\\\/fda-approval-multiple-sclerosis-therapy\\\/\"},\"author\":{\"name\":\"Dr Anne Therese Bernadette Laudato, MD\",\"@id\":\"https:\\\/\\\/staging.scienceinhealth.com\\\/de\\\/#\\\/schema\\\/person\\\/7ce8dda369f9cddd401a3b4c4778153b\"},\"headline\":\"FDA Approval: TG Therapeutics&#8217; 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