{"id":35460,"date":"2025-03-21T13:02:53","date_gmt":"2025-03-21T17:02:53","guid":{"rendered":"https:\/\/nephcure.org\/?p=35460"},"modified":"2025-03-21T13:10:46","modified_gmt":"2025-03-21T17:10:46","slug":"the-fda-approves-fabhalta-first-treatment-option-for-adults-with-c3g","status":"publish","type":"post","link":"https:\/\/nephcure.org\/es\/the-fda-approves-fabhalta-first-treatment-option-for-adults-with-c3g\/","title":{"rendered":"The FDA Approves FABHALTA, First Treatment Option for Adults with C3G"},"content":{"rendered":"<p class=\"wp-block-paragraph\">A historic milestone has been reached for the rare kidney disease (RKD) community \u2014 the FDA has approved the drug FABHALTA as the first-ever treatment option for adults with&nbsp;<a href=\"https:\/\/nephcure.org\/es\/introduccion-a-rkd\/tipos-de-rkd\/complemento-3-glomerulopatia-c3g-ic-mpgn-2\/\">C3 glomerulopathy (C3G)<\/a>. This long-awaited approval brings new hope to patients and families affected by this devastating disease.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">C3G is an ultra-rare, debilitating kidney disease that damages the glomeruli (the filtering units in the kidneys that help remove toxins from the blood) which can ultimately lead to kidney failure. Until now, there were no approved targeted treatment options available for C3G.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u201cThis approval marks a significant step forward in our collective goal to improve the outcomes of those affected by rare kidney diseases. For the first time, the C3G community has a therapy approved and designed specifically for their condition. This comes on the heels of groundbreaking advancements in IgAN, which underscores the current exciting new era of innovation in RKD treatments,\u201d Josh Tarnoff, NephCure\u2019s CEO said.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">FABHALTA\u2019s approval for FABHALTA in C3G is based off Novartis\u2019 Phase 3 study,\u00a0<a href=\"https:\/\/www.novartis.com\/us-en\/news\/media-releases\/novartis-receives-third-fda-approval-oral-fabhalta-iptacopan-first-and-only-treatment-approved-c3-glomerulopathy-c3g\" target=\"_blank\" rel=\"noreferrer noopener\">APARECER-C3G<\/a>, which evaluated the efficacy and safety of the drug and demonstrated reduction in proteinuria, which was seen as early as 14 days.\u00a0<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This marks the third FDA approval, in the U.S., for FABHALTA and its second within the Novartis\u2019 kidney disease portfolio in less than a year. In August 2024,\u00a0<a href=\"https:\/\/www.novartis.com\/news\/media-releases\/novartis-receives-fda-accelerated-approval-fabhalta-iptacopan-first-and-only-complement-inhibitor-reduction-proteinuria-primary-iga-nephropathy-igan\" target=\"_blank\" rel=\"noreferrer noopener\">the drug received accelerated approval<\/a>\u00a0para\u00a0<a href=\"https:\/\/nephcure.org\/es\/introduccion-a-rkd\/tipos-de-rkd\/nefropatia-iga-igan\/\">Nefropat\u00eda por IgA (NIgA)<\/a>.\u00a0<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>A New Era of Kidney Care<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">With this latest breakthrough, there are now&nbsp;<a href=\"https:\/\/nephcure.org\/es\/gestionando-rkd\/opciones-de-tratamiento\/\">four FDA-approved therapies<\/a>&nbsp;for rare kidney disease:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>FABHALTA (iptacopan) \u2013 Approved for C3G and IgAN<\/li>\n\n\n\n<li>FILSPARI (sparsentan) \u2013 Approved for IgAN<\/li>\n\n\n\n<li>TARPEYO (budesonide) \u2013 Approved for IgAN<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">This approval marks an important advancement, but our work is far from over. NephCure remains committed to advancing research, advocacy, and patient education to further improve treatment options and outcomes for those with C3G and other rare kidney diseases. With more than 60&nbsp;<a href=\"https:\/\/nephcure.org\/es\/gestionando-rkd\/ensayos-clinicos\/\">clinical trials in the RKD space<\/a>, we anticipate even more new treatments to be approved in the near future.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Now, the focus shifts to ensuring timely and equitable access to these new and better treatments for all patients.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">If you or a loved one has C3G, we encourage you to speak with your doctor to determine if FABHALTA may be an appropriate treatment option for you.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">To read Novartis\u2019 press release about FABHALTA\u2019s approval for C3G,\u00a0<a href=\"https:\/\/www.novartis.com\/us-en\/news\/media-releases\/novartis-receives-third-fda-approval-oral-fabhalta-iptacopan-first-and-only-treatment-approved-c3-glomerulopathy-c3g\" target=\"_blank\" rel=\"noreferrer noopener\">haga clic aqu\u00ed<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For more information on C3G and available resources, please visit&nbsp;<a href=\"http:\/\/nephcure.org\/es\/\">NephCure.org<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>A historic milestone has been reached for the rare kidney disease (RKD) community \u2014 the FDA has approved the drug FABHALTA as the first-ever treatment option for adults with&nbsp;C3 glomerulopathy &#8230; <a title=\"The FDA Approves FABHALTA, First Treatment Option for Adults with C3G\" class=\"read-more\" href=\"https:\/\/nephcure.org\/es\/the-fda-approves-fabhalta-first-treatment-option-for-adults-with-c3g\/\" aria-label=\"Leer m\u00e1s sobre The FDA Approves FABHALTA, First Treatment Option for Adults with C3G\">Leer m\u00e1s<\/a><\/p>","protected":false},"author":12083,"featured_media":33797,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[300],"tags":[548,462],"disease-category":[],"resource-type":[260],"treatment-option":[],"hf_cat_post":[537],"class_list":["post-35460","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-press-release","tag-c3g","tag-fda-treatments","resource-type-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.1 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>The FDA Approves FABHALTA, First Treatment Option for Adults with C3G - NephCure<\/title>\n<meta name=\"description\" content=\"Celebrate the launch of NephCure&#039;s new online shop. Help raise awareness and support for rare kidney diseases by wearing your support.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/nephcure.org\/es\/the-fda-approves-fabhalta-first-treatment-option-for-adults-with-c3g\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The FDA Approves FABHALTA, First Treatment Option for Adults with C3G\" \/>\n<meta property=\"og:description\" content=\"Celebrate the launch of NephCure&#039;s new online shop. Help raise awareness and support for rare kidney diseases by wearing your support.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/nephcure.org\/es\/the-fda-approves-fabhalta-first-treatment-option-for-adults-with-c3g\/\" \/>\n<meta property=\"og:site_name\" content=\"NephCure\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/nephcure\/\" \/>\n<meta property=\"article:published_time\" content=\"2025-03-21T17:02:53+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-03-21T17:10:46+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/nephcure.org\/wp-content\/uploads\/2024\/08\/NephCure_Simple_Logo_RBG.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"371\" \/>\n\t<meta property=\"og:image:height\" content=\"467\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Hillary Frawley\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@nephcure\" \/>\n<meta name=\"twitter:site\" content=\"@nephcure\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Hillary Frawley\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/nephcure.org\\\/the-fda-approves-fabhalta-first-treatment-option-for-adults-with-c3g\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/nephcure.org\\\/the-fda-approves-fabhalta-first-treatment-option-for-adults-with-c3g\\\/\"},\"author\":{\"name\":\"Hillary Frawley\",\"@id\":\"https:\\\/\\\/nephcure.org\\\/#\\\/schema\\\/person\\\/888138dc7703ee71dc134e639ea6ceed\"},\"headline\":\"The FDA Approves FABHALTA, First Treatment Option for Adults with C3G\",\"datePublished\":\"2025-03-21T17:02:53+00:00\",\"dateModified\":\"2025-03-21T17:10:46+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/nephcure.org\\\/the-fda-approves-fabhalta-first-treatment-option-for-adults-with-c3g\\\/\"},\"wordCount\":430,\"publisher\":{\"@id\":\"https:\\\/\\\/nephcure.org\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/nephcure.org\\\/the-fda-approves-fabhalta-first-treatment-option-for-adults-with-c3g\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/nephcure.org\\\/wp-content\\\/uploads\\\/2024\\\/08\\\/NephCure_Simple_Logo_RBG.jpg\",\"keywords\":[\"C3G\",\"FDA Treatments\"],\"articleSection\":[\"Press Release\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/nephcure.org\\\/the-fda-approves-fabhalta-first-treatment-option-for-adults-with-c3g\\\/\",\"url\":\"https:\\\/\\\/nephcure.org\\\/the-fda-approves-fabhalta-first-treatment-option-for-adults-with-c3g\\\/\",\"name\":\"The FDA Approves FABHALTA, First Treatment Option for Adults with C3G - NephCure\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/nephcure.org\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/nephcure.org\\\/the-fda-approves-fabhalta-first-treatment-option-for-adults-with-c3g\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/nephcure.org\\\/the-fda-approves-fabhalta-first-treatment-option-for-adults-with-c3g\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/nephcure.org\\\/wp-content\\\/uploads\\\/2024\\\/08\\\/NephCure_Simple_Logo_RBG.jpg\",\"datePublished\":\"2025-03-21T17:02:53+00:00\",\"dateModified\":\"2025-03-21T17:10:46+00:00\",\"description\":\"Celebrate the launch of NephCure's new online shop. 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