{"id":78363,"date":"2023-10-30T04:56:00","date_gmt":"2023-10-30T08:56:00","guid":{"rendered":"https:\/\/ifintechworld.com\/investing\/novartis-to-seek-us-accelerated-approval-of-atrasentan-after-phase-3-study-met-primary-goal\/"},"modified":"2023-10-30T04:56:03","modified_gmt":"2023-10-30T08:56:03","slug":"novartis-to-seek-us-accelerated-approval-of-atrasentan-after-phase-3-study-met-primary-goal","status":"publish","type":"post","link":"https:\/\/ifintechworld.com\/?p=78363","title":{"rendered":"Novartis to Seek US Accelerated Approval of Atrasentan After Phase 3 Study Met Primary Goal"},"content":{"rendered":"<div id=\"js-article__body\" itemprop=\"articleBody\" data-sbid=\"MW-BT-CO-20231030-700681\" role=\"document\">\n<p>By Giulia Petroni<\/p>\n<pre><\/pre>\n<p>Novartis will submit an application next year for a possible accelerated approval of atrasentan in the U.S. after its phase 3 study met the primary endpoint.<\/p>\n<p>The Swiss pharmaceutical company said Monday that the study showed a significant reduction in proteinuria, a condition causing high levels of protein in urine, in patients with kidney disease IgA nephropathy.<\/p>\n<div class=\"paywall\">\n<p>Novartis plans to review interim results with the U.S. Food and Drug Administration for a potential regulatory submission for accelerated approval. The study will continue, with final readout expected in the first quarter of 2026, it said.<\/p>\n<pre><\/pre>\n<p>Write to Giulia Petroni at giulia.petroni@wsj.com<\/p>\n<pre><\/pre>\n<\/p><\/div>\n<\/div>\n<p>Read the full article <a href=\"https:\/\/www.marketwatch.com\/story\/novartis-to-seek-us-accelerated-approval-of-atrasentan-after-phase-3-study-met-primary-goal-b40e57a1?mod=investing\" target=\"_blank\" rel=\"noopener\">here<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>By Giulia Petroni Novartis will submit an application next year for a possible accelerated approval of atrasentan in the U.S. after its phase 3 study met the primary endpoint. The Swiss pharmaceutical company said Monday that the study showed a significant reduction in proteinuria, a condition causing high levels of protein in urine, in patients [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1898,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"video","meta":{"footnotes":""},"categories":[239],"tags":[83],"class_list":["post-78363","post","type-post","status-publish","format-video","has-post-thumbnail","hentry","category-investing","tag-featured","post_format-post-format-video"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Novartis to Seek US Accelerated Approval of Atrasentan After Phase 3 Study Met Primary Goal | iFintechWorld<\/title>\n<meta name=\"description\" content=\"By Giulia Petroni Novartis will submit an application next year for a possible accelerated approval of atrasentan in the U.S. after its phase 3 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