{"id":35572,"date":"2025-04-10T13:14:17","date_gmt":"2025-04-10T17:14:17","guid":{"rendered":"https:\/\/nephcure.org\/?p=35572"},"modified":"2025-04-10T13:20:58","modified_gmt":"2025-04-10T17:20:58","slug":"the-fda-grants-accelerated-approval-to-vanrafia-new-treatment-option-for-adults-with-iga-nephropathy","status":"publish","type":"post","link":"https:\/\/nephcure.org\/es\/the-fda-grants-accelerated-approval-to-vanrafia-new-treatment-option-for-adults-with-iga-nephropathy\/","title":{"rendered":"The FDA Grants Accelerated Approval to Vanrafia, New Treatment Option for Adults with IgA Nephropathy"},"content":{"rendered":"<p>A major step forward has been made for the\u00a0<a href=\"https:\/\/nephcure.org\/es\/introduccion-a-rkd\/tipos-de-rkd\/nefropatia-iga-igan\/\" target=\"_blank\" rel=\"noreferrer noopener\">IgA\u00a0Nephropathy (IgAN)<\/a> community. Last week, the FDA granted accelerated approval to Vanrafia (atrasentan), Novartis\u2019 therapy, for adults with primary IgAN at risk of rapid disease progression.\u00a0This approval brings new hope to those affected by this progressive, rare kidney disease.<\/p>\n\n\n\n<p>Como antecedente, el&nbsp;<a href=\"https:\/\/www.fda.gov\/drugs\/nda-and-bla-approvals\/accelerated-approval-program?utm_source=hs_email&amp;utm_medium=email&amp;_hsenc=p2ANqtz--ouCkCjRDdzZVpuwg-GHoY3JvkG4fGUSD8fRLvQkkyroZFXTlaQ0qrvN8B8YOGtTohATNg\" target=\"_blank\" rel=\"noreferrer noopener\">Programa de aprobaci\u00f3n acelerada de la FDA<\/a>&nbsp;allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need.&nbsp;<\/p>\n\n\n\n<p>IgA Nephropathy (IgAN) is a kidney disease in which Immunoglobulin A (IgA) builds up in the kidney. IgA is a protein in the blood and is also part of the immune system. Excess IgA can cause inflammation in the kidney and over time, this leads to scarring in the kidney tissue.\u00a0The severity of kidney disease caused by IgAN varies from person to person. As IgAN progresses, it reduces the kidneys\u2019 ability to filter waste from the blood.<\/p>\n\n\n\n<p>Approval was granted based on interim results from Novartis\u2019 Phase 3 ALIGN trial, which demonstrated a&nbsp;36.1% reduction in proteinuria&nbsp;compared to placebo. Reductions were seen as early as Week 6 and sustained through Week 36. Vanrafia was also shown to have a favorable safety profile, with no new safety signals observed. Ongoing data from the ALIGN study will evaluate whether Vanrafia slows kidney function decline long-term, with final results expected in 2026.<\/p>\n\n\n\n<p>With this latest announcement, there are now four<strong>&nbsp;FDA-approved therapies<\/strong>&nbsp;for IgAN \u2014 a major shift from just a few years ago:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>FABHALTA (iptacopan)<\/strong>\u00a0\u2013 Approved for C3G and IgAN<\/li>\n\n\n\n<li><strong>FILSPARI (esparsent\u00e1n)<\/strong>\u00a0\u2013 Approved for IgAN<\/li>\n\n\n\n<li><strong>TARPEYO (budesonide)<\/strong>\u00a0\u2013 Approved for IgAN<\/li>\n\n\n\n<li><strong>VANRAFIA (atrasentan)<\/strong>\u00a0\u2013 Approved for IgAN<\/li>\n<\/ul>\n\n\n\n<p>Estos <a href=\"https:\/\/nephcure.org\/es\/gestionando-rkd\/opciones-de-tratamiento\/\" target=\"_blank\" rel=\"noreferrer noopener\">Opciones de tratamiento<\/a>, each with different mechanisms of action, allow patients and their care teams to take a more personalized approach to managing this disease.<\/p>\n\n\n\n<p>NephCure remains committed to supporting the IgAN community through continued education, research, and <a href=\"https:\/\/nephcure.org\/es\/involucrarse\/abogacia\/\" target=\"_blank\" rel=\"noreferrer noopener\">Abogac\u00eda<\/a>. While this is an exciting moment, we know the work is far from over. Our focus now turns to ensuring\u00a0timely, affordable, and equitable access\u00a0to these therapies for all who need them.<\/p>\n\n\n\n<p>If you or a loved one has IgAN, we encourage you to speak with your doctor to determine which treatment may be right for you.<\/p>\n\n\n\n<p>To read Novartis\u2019 full press release about Vanrafia\u2019s FDA approval,\u00a0<a href=\"https:\/\/www.novartis.com\/news\/media-releases\/novartis-receives-fda-accelerated-approval-vanrafia-atrasentan-first-and-only-selective-endothelin-receptor-antagonist-proteinuria-reduction-primary-iga-nephropathy-igan\" target=\"_blank\" rel=\"noreferrer noopener\">haga clic aqu\u00ed<\/a>.<\/p>\n\n\n\n<p>For more information on IgA Nephropathy, <a href=\"https:\/\/nephcure.org\/es\/introduccion-a-rkd\/tipos-de-rkd\/nefropatia-iga-igan\/\" target=\"_blank\" rel=\"noreferrer noopener\">haga clic aqu\u00ed<\/a>. To view and read the available resources about IgAN, please visit\u00a0<a href=\"https:\/\/nephcure.org\/es\/apoyo\/recursos\/\" target=\"_blank\" rel=\"noreferrer noopener\">NephCure.org<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>A major step forward has been made for the\u00a0IgA\u00a0Nephropathy (IgAN) community. Last week, the FDA granted accelerated approval to Vanrafia (atrasentan), Novartis\u2019 therapy, for adults with primary IgAN at risk &#8230; <a title=\"The FDA Grants Accelerated Approval to Vanrafia, New Treatment Option for Adults with IgA Nephropathy\" class=\"read-more\" href=\"https:\/\/nephcure.org\/es\/the-fda-grants-accelerated-approval-to-vanrafia-new-treatment-option-for-adults-with-iga-nephropathy\/\" aria-label=\"Leer m\u00e1s sobre The FDA Grants Accelerated Approval to Vanrafia, New Treatment Option for Adults with IgA Nephropathy\">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":[462,383,556],"disease-category":[255],"resource-type":[260],"treatment-option":[],"hf_cat_post":[537],"class_list":["post-35572","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-press-release","tag-fda-treatments","tag-iga-nephropathy","tag-igan","disease-category-iga-nephropathy-igan","resource-type-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>The FDA Grants Accelerated Approval to Vanrafia, New Treatment Option for Adults with IgA Nephropathy - NephCure<\/title>\n<meta name=\"description\" content=\"Learn about 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