{"id":2465,"date":"2025-05-28T07:00:00","date_gmt":"2025-05-28T07:00:00","guid":{"rendered":"https:\/\/healthscience.institute\/?p=2465"},"modified":"2026-08-31T16:00:06","modified_gmt":"2026-08-31T16:00:06","slug":"fda-approval-multiple-sclerosis-therapy","status":"publish","type":"post","link":"https:\/\/scienceinhealth.com\/sv\/2025\/05\/28\/fda-approval-multiple-sclerosis-therapy\/","title":{"rendered":"FDA-godk\u00e4nnande: TG Therapeutics \u2019 Genombrott f\u00f6r multipel skleros"},"content":{"rendered":"<h2 class=\"wp-block-heading\"><strong>En terapi som passar in i en lunchpaus<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">F\u00f6rest\u00e4ll dig att behandla multipel skleros med bara en timmes IV-infusion tv\u00e5 g\u00e5nger om \u00e5ret \u2014 en terapi s\u00e5 bekv\u00e4m men \u00e4nd\u00e5 kraftfull att den dramatiskt kan s\u00e4nka \u00e5terfallshastigheterna. I slutet av 2022 blev detta verklighet n\u00e4r TG Therapeutics \u2019 nya l\u00e4kemedel Briumvi (ublituximab-xiiy) fick FDA-godk\u00e4nnande<sup>1<\/sup>. Briumvi \u00e4r en laboratoriekonstruerad antikropp som riktar sig mot immunceller som \u00e4r k\u00e4nda f\u00f6r att driva MS. Dess godk\u00e4nnande markerar ett lovande nytt kapitel i MS-v\u00e5rd, och erbjuder h\u00f6g effekt med ett kortare och enklare doseringsschema \u00e4n m\u00e5nga befintliga terapier.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Varf\u00f6r detta godk\u00e4nnande kan omforma MS-behandling<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Multipel skleros (MS) \u00e4r ett kroniskt immunmedierat symptom d\u00e4r kroppen attackerar den skyddande bel\u00e4ggningen av nerver, vilket resulterar i symtom fr\u00e5n tr\u00f6tthet och r\u00f6rlighetsbegr\u00e4nsningar till kognitiva st\u00f6rningar. Det b\u00f6rjar ofta i tidig vuxen \u00e5lder \u2014 precis som m\u00e5nga etablerar karri\u00e4rer och familjer. Medan mer \u00e4n 20 FDA-godk\u00e4nda sjukdomsmodifierande terapier (DMT) finns, kommer m\u00e5nga med avv\u00e4gningar: ofta dosering, l\u00e5nga infusionstider eller immunrelaterade biverkningar<sup>2<\/sup>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">FDA: s godk\u00e4nnande av Briumvi den 28 december 2022 signalerade ett stort steg fram\u00e5t<sup>1<\/sup>. Det blev den tredje anti-CD20-terapin som godk\u00e4nts f\u00f6r MS efter Ocrevus (ocrelizumab) och Kesimpta (ofatumumab). Briumvi \u00e4r dock den f\u00f6rsta och enda som kan infunderas p\u00e5 bara en timme f\u00f6r underh\u00e5llsdoser<sup>3<\/sup>. \u201cGodk\u00e4nnandet av Briumvi \u00e4r underbara nyheter, \u201d sade Juni Halper, VD f\u00f6r Consortium of MS Centers, och betonade dess betydelse f\u00f6r personer som diagnostiserats under de mest aktiva \u00e5ren i livet.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"http:\/\/scienceinhealth.com\/sv\/newsletter\/\">Prenumerera gratis f\u00f6r mer insiktsfulla h\u00e4lsoartiklar anpassade efter dina behov.<\/a><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Handelsbidragen som fortfarande st\u00e5r inf\u00f6r<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Trots vetenskapliga framsteg st\u00e5r MS-anv\u00e4ndare fortfarande inf\u00f6r stora hinder:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Bekv\u00e4mlighet kontra effektivitet:<\/strong> Kraftfulla terapier som Ocrevus kr\u00e4ver 3- till 4-timmars infusioner tv\u00e5 g\u00e5nger om \u00e5ret<sup>5<\/sup>, medan andra som Kesimpta kr\u00e4ver m\u00e5natliga sj\u00e4lvinjektioner.<\/li>\n\n\n\n<li><strong>S\u00e4kerhet och tolerabilitet:<\/strong> Immunundertryckning \u00f6kar risken f\u00f6r infektioner och infusionsreaktioner.<\/li>\n\n\n\n<li><strong>Kostnad och komplexitet:<\/strong> Behandlingskostnaderna kan vara h\u00e4pnadsv\u00e4ckande \u2014 vissa som \u00f6verstiger $ 70 000 \/ \u00e5r \u2014 och s\u00e4tter press p\u00e5 b\u00e5de anv\u00e4ndare och h\u00e4lsosystem<sup>6<\/sup>.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Briumvis infusionsformat p\u00e5 en timme utformades f\u00f6r att minska denna b\u00f6rda samtidigt som den bibeh\u00f6ll h\u00f6g effektivitet<sup>3<\/sup>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Hur Briumvi fungerar p\u00e5 cellniv\u00e5<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Forskning har visat att vissa B-celler \u2014 immuna celler markerade av <strong>CD20-protein<\/strong>\u2014spelar en nyckelroll i MS-inflammation. Dessa celler interagerar med T-celler och uppmuntrar dem att attackera myelin, den skyddande manteln runt nerverna<sup>7<\/sup>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Briumvi \u00e4r en CD20-riktad monoklonal antikropp, vilket betyder att den binder till CD20 p\u00e5 dessa skadliga B-celler och flaggar dem f\u00f6r f\u00f6rst\u00f6relse. Det som g\u00f6r Briumvi unik \u00e4r att det \u00e4r glycoengineered f\u00f6r att f\u00f6rb\u00e4ttra kroppens naturliga f\u00f6rm\u00e5ga att eliminera dessa celler via antikroppsberoende cellcytotoxicitet<sup>8<\/sup>.J\u00e4mf\u00f6rt med \u00e4ldre CD20-terapier erbjuder Briumvi en mindre dos (450 mg) och en snabbare infusionstid utan att kompromissa med immunmodulering.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Vad uppgifterna ber\u00e4ttar om Briumvi's Performance<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Briumvi's FDA-godk\u00e4nnande baserades p\u00e5 tv\u00e5 fas 3-studier \u2014 UTIMATE I och II \u2014 som registrerade 1 094 deltagare med \u00e5terfallande MS<sup>10<\/sup>. Dessa var dubbelblinda, dubbel-dummy-studier som j\u00e4mf\u00f6r Briumvi med teriflunomid (Aubagio) under 96 veckor.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Viktiga resultat:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u00c5rlig \u00e5terfallsgrad (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 mot 0,18<strong><br><\/strong> Detta representerar en reduktion p\u00e5 50 \u2013 60% i \u00e5terfallsfrekvens<sup>10<\/sup>.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>MR-hj\u00e4rnskador:<br><\/strong> Briumvi-anv\u00e4ndare hade n\u00e4stan noll nya gadoliniumf\u00f6rb\u00e4ttrande lesioner p\u00e5 MRI, j\u00e4mf\u00f6rt med ungef\u00e4r 0,5 i teriflunomidgruppen \u2014 en ~ 95% minskning av ny hj\u00e4rninflammation<sup>11<\/sup>.<\/li>\n\n\n\n<li><strong>Inget bevis f\u00f6r sjukdomsaktivitet (NEDA):<\/strong>\n<ul class=\"wp-block-list\">\n<li>ULTIMAT I: 44,6% uppn\u00e5dde NEDA vs. <strong>15%<\/strong><\/li>\n\n\n\n<li>ULTIMATE II: 43% vs. 11.4%<br> Att uppn\u00e5 NEDA \u00e4r guldstandarden inom MS-v\u00e5rd<sup>12<\/sup>.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Handikappprogression:<br><\/strong> Det fanns ingen signifikant skillnad i f\u00f6rs\u00e4mring av funktionshinder mellan grupper (5,2% mot 5,9%), \u00e4ven om fler Briumvi-anv\u00e4ndare visade tecken p\u00e5 f\u00f6rb\u00e4ttring av funktionshinder<sup>13<\/sup>.<\/li>\n\n\n\n<li><strong>S\u00e4kerhet<\/strong>: <br>De vanligaste biverkningarna var infusionsrelaterade reaktioner (47,7%), vanligtvis milda till m\u00e5ttliga. F\u00f6rbehandling med steroider och antihistaminer hj\u00e4lpte till att hantera dessa h\u00e4ndelser<sup>13<\/sup>.<br>Allvarliga infektioner intr\u00e4ffade hos 5,0% av Briumvi-anv\u00e4ndare j\u00e4mf\u00f6rt med 2,9% p\u00e5 teriflunomid<sup>13<\/sup>.<br>Det \u00e4r viktigt att inga fall av PML (en s\u00e4llsynt hj\u00e4rninfektion) intr\u00e4ffade i n\u00e5gon grupp<sup>14<\/sup>.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"http:\/\/scienceinhealth.com\/sv\/newsletter\/\">Prenumerera gratis f\u00f6r mer insiktsfulla h\u00e4lsoartiklar anpassade efter dina behov.<\/a><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Vad detta betyder i den verkliga v\u00e4rlden<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">F\u00f6r m\u00e5nga kan Briumvis kortare infusionstid vara livsf\u00f6r\u00e4ndrande. En halvtimmes tv\u00e5\u00e5rsutn\u00e4mning, snarare \u00e4n en fler timmars infusion eller m\u00e5nadsinjektion, kan frig\u00f6ra dussintals timmar per \u00e5r. Det \u00e4r en meningsfull f\u00f6r\u00e4ndring f\u00f6r f\u00f6r\u00e4ldrar, yrkesverksamma och v\u00e5rdgivare som f\u00f6rs\u00f6ker balansera behandlingen med livskrav<sup>5<\/sup>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kliniker gynnas ocks\u00e5: kortare infusioner \u00f6kar patientens genomstr\u00f6mning och l\u00e4gre kostnader. Briumvis listpris \u2014 $ 59 000 \/ \u00e5r \u2014 \u00e4r s\u00e4rskilt l\u00e4gre \u00e4n konkurrenter som Ocrevus, som listar cirka 71 000 USD \/ \u00e5r<sup>6<\/sup>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>\u201cF\u00f6r dig som inte gillar injektioner eller har begr\u00e4nsad tid f\u00f6r infusioner \u00e4r denna nya DMT v\u00e4rd att diskutera med din neurolog, \u201d<\/em> skrev MS-kolumnisten Ed Tobias<sup>15<\/sup>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Vad du ska fr\u00e5ga din h\u00e4lso-och sjukv\u00e5rdspersonal<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Om du eller n\u00e5gon du k\u00e4nner lever med \u00e5terfallande MS, fr\u00e5ga din sjukv\u00e5rdspersonal om Briumvi kan vara ett alternativ. F\u00f6r mer, bes\u00f6k FDA: s godk\u00e4nnande\u00f6versikt eller utforska supportresurser fr\u00e5n<a href=\"https:\/\/www.nationalmssociety.org\/\"> National MS Society<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Artikeln utg\u00f6r inte p\u00e5 n\u00e5got s\u00e4tt som medicinsk r\u00e5dgivning. V\u00e4nligen kontakta en licensierad l\u00e4kare innan du p\u00e5b\u00f6rjar n\u00e5gon behandling. Denna webbplats kan ta emot provisioner fr\u00e5n l\u00e4nkarna eller produkterna som n\u00e4mns i den h\u00e4r artikeln.<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"http:\/\/scienceinhealth.com\/sv\/newsletter\/\">Prenumerera gratis f\u00f6r mer insiktsfulla h\u00e4lsoartiklar anpassade efter dina behov.<\/a><\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Fotnoter<\/strong><\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li>U.S. Food &amp; Drug Administration. \u201cFDA godk\u00e4nner Briumvi f\u00f6r \u00e5terfall av former av multipel skleros. \u201d 28 december 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>Neurologi<\/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>En terapi som passar in i en lunchpaus F\u00f6rest\u00e4ll dig att behandla multipel skleros med bara en timmes IV-infusion tv\u00e5 g\u00e5nger ...<\/p>","protected":false},"author":13,"featured_media":1694,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"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"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - 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=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/scienceinhealth.com\/sv\/2025\/05\/28\/fda-approval-multiple-sclerosis-therapy\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\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:\/\/scienceinhealth.com\/sv\/2025\/05\/28\/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=\"2026-08-31T16:00:06+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/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=\"Skriven av\" \/>\n\t<meta name=\"twitter:data1\" content=\"Dr Anne Therese Bernadette Laudato, MD\" \/>\n\t<meta name=\"twitter:label2\" content=\"Ber\u00e4knad l\u00e4stid\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minuter\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/scienceinhealth.com\\\/2025\\\/05\\\/28\\\/fda-approval-multiple-sclerosis-therapy\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/scienceinhealth.com\\\/2025\\\/05\\\/28\\\/fda-approval-multiple-sclerosis-therapy\\\/\"},\"author\":{\"name\":\"Dr Anne Therese Bernadette Laudato, MD\",\"@id\":\"https:\\\/\\\/scienceinhealth.com\\\/de\\\/#\\\/schema\\\/person\\\/5128aec7f438bd73bb5a6a3bc5b90de3\"},\"headline\":\"FDA Approval: TG Therapeutics&#8217; 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