{"id":10412,"date":"2019-10-22T19:04:16","date_gmt":"2019-10-22T13:34:16","guid":{"rendered":"https:\/\/www.rootsanalysis.com\/blog\/?p=10412"},"modified":"2026-07-08T17:39:10","modified_gmt":"2026-07-08T12:09:10","slug":"alzheimers-pipeline-update-biogen-takes-a-u-turn-on-failed-drugs-approval-in-sight","status":"publish","type":"post","link":"https:\/\/www.rootsanalysis.com\/blog\/alzheimers-pipeline-update-biogen-takes-a-u-turn-on-failed-drugs-approval-in-sight\/","title":{"rendered":"Alzheimer&#8217;s Pipeline Update: Biogen Takes a U-Turn on Failed Drug; Approval in Sight"},"content":{"rendered":"<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"284\" src=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Roots-1024x284.webp\" alt=\"Alzheimer's Pipeline illustrative image only \" class=\"wp-image-17561\" style=\"object-fit:contain;width:600px;height:167px\" srcset=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Roots-1024x284.webp 1024w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Roots-300x83.webp 300w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Roots-768x213.webp 768w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Roots-1536x426.webp 1536w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Roots.webp 2000w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">In one of the most drastic shifts in fortune in the pharmaceutical industry, Biogen has decided to submit its <a href=\"https:\/\/www.bloomberg.com\/news\/articles\/2019-03-21\/biogen-halts-study-of-alzheimer-s-treatment-as-study-falls-short\">previously failed<\/a> Alzheimer&#8217;s drug for approval. <a href=\"http:\/\/media.biogen.com\/news-releases\/news-release-details\/biogen-plans-regulatory-filing-aducanumab-alzheimers-disease\">According to the company<\/a>,&nbsp;The Phase 3 EMERGE (<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02484547\">NCT02484547<\/a>) study met its primary endpoint showing a significant reduction in clinical decline, and Biogen believes that results from a subset of patients in Phase 3 ENGAGE (<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02477800\">NCT02477800<\/a>) study who received sufficient exposure to high dose aducanumab support the findings from EMERGE. <a href=\"https:\/\/www.bloomberg.com\/news\/articles\/2019-10-22\/biogen-will-take-alzheimer-s-treatment-to-fda-reviving-hope\">According to Bloomberg<\/a>, the company does not believe it needs to conduct additional trials of the drug before moving ahead.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Here are some of the key takeaways from the company&#8217;s new announcement:<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The decision to file is based on a new analysis, conducted by Biogen in consultation with the FDA, of a larger dataset from the Phase 3 clinical studies that were discontinued in March 2019 following a futility analysis.<\/li>\n\n\n\n<li>This new analysis of a larger dataset that includes additional data that became available after the pre-specified futility analysis shows that aducanumab is pharmacologically and clinically active as&nbsp;determined by dose-dependent effects in reducing brain amyloid.<\/li>\n\n\n\n<li>In addition, the drug is effective in&nbsp;reducing clinical decline as assessed by the pre-specified primary endpoint Clinical Dementia Rating-Sum of Boxes (CDR-SB).<\/li>\n\n\n\n<li>In both studies, the safety and tolerability profile of aducanumab was consistent with prior studies of aducanumab.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">This is big news for patients suffering from Alzheimer&#8217;s.<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"147\" src=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Growing-Disease-Burdon-Roots-1024x147.webp\" alt=\"\" class=\"wp-image-17563\" style=\"object-fit:contain;width:800px;height:119px\" srcset=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Growing-Disease-Burdon-Roots-1024x147.webp 1024w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Growing-Disease-Burdon-Roots-300x43.webp 300w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Growing-Disease-Burdon-Roots-768x110.webp 768w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Growing-Disease-Burdon-Roots-1536x221.webp 1536w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Growing-Disease-Burdon-Roots.webp 1908w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<\/div>\n\n\n<h2 class=\"wp-block-heading\"><strong>Impact on the Development Landscape of Alzheimer&#8217;s:<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Currently, more than 200 candidates are&nbsp;under development in the clinical and preclinical stages for the treatment of patients with Alzheimer&#8217;s. With over 600 active clinical trials, the research efforts have progressed significantly in this space. Below is a quick snapshot of the development pipeline:<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"562\" src=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Development-Pipeline-Roots-1024x562.webp\" alt=\"Alzheimer disease has solid pipeline as shown in the graph by Roots Analysis\" class=\"wp-image-17564\" style=\"object-fit:contain;width:800px;height:443px\" srcset=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Development-Pipeline-Roots-1024x562.webp 1024w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Development-Pipeline-Roots-300x165.webp 300w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Development-Pipeline-Roots-768x422.webp 768w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Development-Pipeline-Roots.webp 1102w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">Given the long history of failed drugs in this space, this news comes as a big sigh of relief for drug developers. Below, I have added a quick snapshot showing the history of drug failures in Alzheimer&#8217;s diseases:<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"453\" src=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Terminated-Clinical-Trials-Roots-1024x453.webp\" alt=\"\" class=\"wp-image-17565\" style=\"object-fit:contain;width:800px;height:356px\" srcset=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Terminated-Clinical-Trials-Roots-1024x453.webp 1024w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Terminated-Clinical-Trials-Roots-300x133.webp 300w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Terminated-Clinical-Trials-Roots-768x340.webp 768w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Terminated-Clinical-Trials-Roots-1536x680.webp 1536w, https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2023\/10\/Alzheimers-Terminated-Clinical-Trials-Roots.webp 1957w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">To get more insights about the Alzheimer&#8217;s Disease development landscape, check out the report <a href=\"https:\/\/www.rootsanalysis.com\/reports\/alzheimers-disease-market\/247.html\">Alzheimer Disease Drug Discovery Market<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In one of the most drastic shifts in fortune in the pharmaceutical industry, Biogen has decided to submit its previously failed Alzheimer&#8217;s drug for approval. According to the company,&nbsp;The Phase 3 EMERGE (NCT02484547) study met its primary endpoint showing a significant reduction in clinical decline, and Biogen believes that results from a subset of patients [&hellip;]<\/p>\n","protected":false},"author":21,"featured_media":17312,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[335],"tags":[],"class_list":["post-10412","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-alzheimers-pipeline"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Alzheimer&#039;s Pipeline Update: Biogen Takes a U-Turn on Failed<\/title>\n<meta name=\"description\" content=\"Alzheimer&#039;s one of the most drastic shifts in fortune in the pharmaceutical industry, Biogen has decided to submit.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.rootsanalysis.com\/blog\/alzheimers-pipeline-update-biogen-takes-a-u-turn-on-failed-drugs-approval-in-sight\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Alzheimer&#039;s Pipeline Update: Biogen Takes a U-Turn on Failed\" \/>\n<meta property=\"og:description\" content=\"Alzheimer&#039;s one of the most drastic shifts in fortune in the pharmaceutical industry, Biogen has decided to submit.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.rootsanalysis.com\/blog\/alzheimers-pipeline-update-biogen-takes-a-u-turn-on-failed-drugs-approval-in-sight\/\" \/>\n<meta property=\"og:site_name\" content=\"Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RootsAnalysis\/\" \/>\n<meta property=\"article:published_time\" content=\"2019-10-22T13:34:16+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-07-08T12:09:10+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.rootsanalysis.com\/blog\/wp-content\/uploads\/2019\/10\/RootsAnalysis_FeaturedImage_Alzheimer.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"150\" \/>\n\t<meta property=\"og:image:height\" content=\"150\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"author\" content=\"Gaurav Chaudhary\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@RootsAnalysis\" \/>\n<meta name=\"twitter:site\" content=\"@RootsAnalysis\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Gaurav Chaudhary\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.rootsanalysis.com\\\/blog\\\/alzheimers-pipeline-update-biogen-takes-a-u-turn-on-failed-drugs-approval-in-sight\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.rootsanalysis.com\\\/blog\\\/alzheimers-pipeline-update-biogen-takes-a-u-turn-on-failed-drugs-approval-in-sight\\\/\"},\"author\":{\"name\":\"Gaurav Chaudhary\",\"@id\":\"https:\\\/\\\/www.rootsanalysis.com\\\/blog\\\/#\\\/schema\\\/person\\\/e8e0ebc31296140424e1e7fcc11331bc\"},\"headline\":\"Alzheimer&#8217;s Pipeline Update: Biogen Takes a U-Turn on Failed Drug; 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