{"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\/es\/2025\/05\/28\/fda-approval-multiple-sclerosis-therapy\/","title":{"rendered":"Aprobaci\u00f3n de la FDA: El gran avance de TG Therapeutics para la esclerosis m\u00faltiple"},"content":{"rendered":"<h2 class=\"wp-block-heading\"><strong>Una terapia que encaja en un descanso para almorzar<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Imaginemos tratar la esclerosis m\u00faltiple con una infusi\u00f3n intravenosa de s\u00f3lo una hora dos veces al a\u00f1o, una terapia tan conveniente pero poderosa que puede reducir dr\u00e1sticamente las tasas de reca\u00edda. A finales de 2022, esto se hizo realidad cuando el nuevo medicamento Briumvi (ublituximab-xiiy) de TG Therapeutics obtuvo la aprobaci\u00f3n de la FDA.<sup>1<\/sup>. Briumvi es un anticuerpo dise\u00f1ado en laboratorio que apunta a las c\u00e9lulas inmunitarias conocidas por conducir la EM. Su aprobaci\u00f3n marca un nuevo y prometedor cap\u00edtulo en la atenci\u00f3n de la EM, ofreciendo una alta eficacia con un cronograma de dosificaci\u00f3n m\u00e1s corto y f\u00e1cil que muchas terapias existentes.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Por qu\u00e9 esta aprobaci\u00f3n podr\u00eda reformular el tratamiento de la EM<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">La esclerosis m\u00faltiple (EM) es un s\u00edntoma cr\u00f3nico mediado por el sistema inmunitario en el que el cuerpo ataca la capa protectora de los nervios, dando lugar a s\u00edntomas como fatiga y limitaciones de movilidad o trastornos cognitivos. A menudo comienza en la temprana edad adulta, al igual que muchos est\u00e1n estableciendo carreras y familias. Si bien existen m\u00e1s de 20 terapias modificadoras de la enfermedad (TMD) aprobadas por la FDA, muchas tienen desventajas: dosis frecuentes, largos tiempos de infusi\u00f3n o efectos secundarios relacionados con el sistema inmunitario.<sup>2<\/sup>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">La aprobaci\u00f3n de Briumvi por parte de la FDA el 28 de diciembre de 2022 marc\u00f3 un importante paso adelante<sup>1<\/sup>. Se convirti\u00f3 en la tercera terapia anti-CD20 aprobada para EM, despu\u00e9s de Ocrevus (ocrelizumab) y Kesimpta (ofatumumab). Sin embargo, Briumvi es el primero y \u00fanico que se puede infundir en solo una hora para las dosis de mantenimiento<sup>3<\/sup>.\"La aprobaci\u00f3n de Briumvi es una noticia maravillosa\", dijo June Halper, directora ejecutiva del Consorcio de MS Centers, enfatizando su importancia para las personas diagnosticadas durante los a\u00f1os m\u00e1s activos de la vida.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"http:\/\/scienceinhealth.com\/es\/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>Los pacientes siguen teniendo que hacer concesiones<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">A pesar del progreso cient\u00edfico, los usuarios de la esclerosis m\u00faltiple todav\u00eda enfrentan obst\u00e1culos importantes:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Conveniencia vs. eficacia:<\/strong> Las terapias potentes como Ocrevus requieren infusiones de 3 a 4 horas dos veces al a\u00f1o<sup>5<\/sup>, mientras que otros como Kesimpta exigen autoinyecciones mensuales.<\/li>\n\n\n\n<li><strong>Seguridad y tolerabilidad:<\/strong> La inmunosupresi\u00f3n aumenta el riesgo de infecciones y reacciones de infusi\u00f3n.<\/li>\n\n\n\n<li><strong>Costo y complejidad:<\/strong> Los costos del tratamiento pueden ser enormes -algunos superan los 70.000 d\u00f3lares al a\u00f1o-, lo que ejerce presi\u00f3n sobre los usuarios y los sistemas de salud<sup>6<\/sup>.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">El formato de infusi\u00f3n de una hora de Briumvi fue dise\u00f1ado para reducir esta carga mientras se mantiene una alta efectividad.<sup>3<\/sup>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>C\u00f3mo funciona Briumvi a nivel celular<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">La investigaci\u00f3n ha demostrado que ciertas c\u00e9lulas B inmunes est\u00e1n marcadas por el <strong>prote\u00edna CD20<\/strong>-desempe\u00f1an un papel clave en la inflamaci\u00f3n de la esclerosis m\u00faltiple. Estas c\u00e9lulas interact\u00faan con las c\u00e9lulas T, alent\u00e1ndolas a atacar la mielina, la vaina protectora que rodea los nervios.<sup>7<\/sup>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Briumvi es un anticuerpo monoclonal dirigido por el CD20, lo que significa que se une al CD20 en estas c\u00e9lulas B da\u00f1inas y las marca para su destrucci\u00f3n. Lo que hace \u00fanico a Briumvi es que est\u00e1 glicodise\u00f1ado para mejorar la capacidad natural del cuerpo de eliminar estas c\u00e9lulas mediante citotoxicidad celular dependiente de anticuerpos<sup>8<\/sup>.En comparaci\u00f3n con las terapias CD20 m\u00e1s antiguas, Briumvi ofrece una dosis menor (450 mg) y un tiempo de infusi\u00f3n m\u00e1s r\u00e1pido, sin comprometer la modulaci\u00f3n inmune.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Lo que los datos nos dicen sobre el rendimiento de Briumvi<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">La aprobaci\u00f3n de la FDA por parte de Briumvi se bas\u00f3 en dos estudios de fase 3 -ULTIMATE I y II- que reclutaron a 1.094 participantes con EM recidivante<sup>10<\/sup>. Estos fueron ensayos doble ciego y doble dummy que compararon a Briumvi con teriflunomide (Aubagio) durante 96 semanas.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Conclusiones principales:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Tasa de reca\u00edda anualizada (ARR):<\/strong>\n<ul class=\"wp-block-list\">\n<li>ULTIMATE I: 0,08 reca\u00eddas\/a\u00f1o (Briumvi) vs. 0,19 (teriflunomida)<\/li>\n\n\n\n<li>ULTIMATE II: 0.09 vs. 0.18<strong><br><\/strong> Esto representa una reducci\u00f3n del 50-60% en la frecuencia de reca\u00eddas<sup>10<\/sup>.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Lesiones cerebrales por resonancia magn\u00e9tica:<br><\/strong> Los usuarios de Briumvi ten\u00edan casi cero nuevas lesiones que mejoraban el gadolinio en la resonancia magn\u00e9tica, comparado con aproximadamente 0,5 en el grupo de teriflunomida-una reducci\u00f3n del 95% en la nueva inflamaci\u00f3n cerebral<sup>11<\/sup>.<\/li>\n\n\n\n<li><strong>No hay evidencia de actividad de la enfermedad (NEDA):<\/strong>\n<ul class=\"wp-block-list\">\n<li>ULTIMATE I: 44.6% logr\u00f3 el NEDA vs. <strong>15%<\/strong><\/li>\n\n\n\n<li>ULTIMATE II: 43% vs. 11.4%<br> Lograr el NEDA es el est\u00e1ndar de oro en la atenci\u00f3n a pacientes con esclerosis m\u00faltiple<sup>12<\/sup>.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Progresi\u00f3n de la discapacidad:<br><\/strong> No hubo una diferencia significativa en el empeoramiento de la discapacidad entre los grupos (5,2% vs. 5,9%), aunque m\u00e1s usuarios de Briumvi mostraron signos de mejora de la discapacidad<sup>13<\/sup>.<\/li>\n\n\n\n<li><strong>Seguridad<\/strong>: <br>Los efectos secundarios m\u00e1s comunes fueron reacciones relacionadas con la infusi\u00f3n (47,7%), t\u00edpicamente leves a moderadas. El tratamiento previo con esteroides y antihistam\u00ednicos ayud\u00f3 a manejar estos eventos<sup>13<\/sup>.<br>Se produjeron infecciones graves en el 5,0% de los usuarios de Briumvi frente al 2,9% de los que tomaron teriflunomida.<sup>13<\/sup>.<br>Es importante destacar que no hubo casos de PML (una infecci\u00f3n cerebral rara) en ninguno de los grupos<sup>14<\/sup>.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"http:\/\/scienceinhealth.com\/es\/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>Lo que esto significa en el mundo real<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Para muchos, el tiempo de infusi\u00f3n m\u00e1s corto de Briumvi podr\u00eda cambiar la vida. Una cita de una hora cada dos a\u00f1os, en lugar de una infusi\u00f3n de varias horas o una inyecci\u00f3n mensual, podr\u00eda liberar decenas de horas al a\u00f1o. Es un cambio significativo para los padres, profesionales y cuidadores que intentan equilibrar el tratamiento con las exigencias de la vida<sup>5<\/sup>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Las cl\u00ednicas tambi\u00e9n se benefician: las infusiones m\u00e1s cortas aumentan el rendimiento de los pacientes y reducen los costos. El precio de lista de Briumvi-$59,000\/a\u00f1o- es notablemente m\u00e1s bajo que competidores como Ocrevus, que cotiza alrededor de $71,000\/a\u00f1o<sup>6<\/sup>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>\"Para aquellos a los que no les gustan las inyecciones o tienen poco tiempo para las infusiones, vale la pena discutir este nuevo DMT con su neur\u00f3logo,\"<\/em> escribi\u00f3 el columnista de MS Ed Tobias<sup>15<\/sup>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Qu\u00e9 preguntar a tu profesional de la salud<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Si usted o alguien que conoce tiene EM recurrente, pregunte a su profesional sanitario si Briumvi podr\u00eda ser una opci\u00f3n. Para obtener m\u00e1s informaci\u00f3n, visite el resumen de aprobaci\u00f3n de la FDA o explore los recursos de soporte del<a href=\"https:\/\/www.nationalmssociety.org\/\"> Sociedad Nacional de EM<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><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 class=\"wp-block-paragraph\"><strong><a href=\"http:\/\/scienceinhealth.com\/es\/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>Neurolog\u00eda<\/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>Una terapia que encaja en un descanso para el almuerzo Imagine tratar la esclerosis m\u00faltiple con solo una infusi\u00f3n intravenosa de una hora dos veces...<\/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 v28.7 - 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\/es\/2025\/05\/28\/fda-approval-multiple-sclerosis-therapy\/\" \/>\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:\/\/scienceinhealth.com\/es\/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=\"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:\\\/\\\/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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