{"id":2953,"date":"2026-07-14T06:32:27","date_gmt":"2026-07-14T06:32:27","guid":{"rendered":"https:\/\/whmnews.ir\/En\/?p=2953"},"modified":"2026-07-14T06:32:27","modified_gmt":"2026-07-14T06:32:27","slug":"fda-approves-at-home-starter-dose-of-eisai-biogen-alzheimers-drug","status":"publish","type":"post","link":"https:\/\/whmnews.ir\/En\/index.php\/2026\/07\/14\/fda-approves-at-home-starter-dose-of-eisai-biogen-alzheimers-drug\/","title":{"rendered":"FDA approves at-home starter dose of Eisai-Biogen Alzheimer&#8217;s drug"},"content":{"rendered":"<p style=\"text-align: justify;\"><strong>FDA approves at-home starter dose of Eisai-Biogen Alzheimer&#8217;s drug<\/strong><\/p>\n<p style=\"text-align: justify;\">The U.S. FDA on Monday approved an at-home starting dose of Eisai&#8217;s\u00a0<a href=\"https:\/\/www.reuters.com\/markets\/companies\/4523.T\">(4523.T), opens new tab<\/a>\u00a0and Biogen&#8217;s\u00a0<a href=\"https:\/\/www.reuters.com\/markets\/companies\/BIIB.O\">(BIIB.O), opens new tab<\/a>\u00a0Alzheimer&#8217;s drug, allowing \u200bsome patients to begin therapy with injections administered by themselves \u200cor a caregiver.<\/p>\n<p style=\"text-align: justify;\">Shares of Biogen were up 4.5% in afternoon trading.<\/p>\n<ul>\n<li style=\"text-align: justify;\">The approval applies to an under-the-skin formulation of the drug branded as Leqembi.<\/li>\n<li style=\"text-align: justify;\">Until now, patients starting \u200btreatment received the drug through intravenous infusions, typically given at a \u200bclinic, and could later switch to maintenance treatment after 18 \u2060months.<\/li>\n<li style=\"text-align: justify;\">Leqembi&#8217;s at-home subcutaneous approval could increase uptake by improving patient access \u200band differentiating it from Eli Lilly&#8217;s\u00a0<a href=\"https:\/\/www.reuters.com\/markets\/companies\/LLY.N\">(LLY.N), opens new tab<\/a>\u00a0Kisunla, which requires intravenous infusions, said \u200bBMO Capital Markets analyst Evan Seigerman.<\/li>\n<li style=\"text-align: justify;\">Leqembi is already authorized for adults with Alzheimer&#8217;s disease, a progressive brain disorder that affects memory, thinking and daily function. The drug \u200btargets amyloid beta, a protein that forms plaques in the brains of \u200bpeople with the disease.<\/li>\n<li style=\"text-align: justify;\">Citi analysts said they do not expect the approval to drive \u200cimmediate \u2060commercial inflection, as hurdles such as patient identification, diagnostic confirmation, monitoring requirements, specialist availability and reimbursement access remain key barriers on adoption.<\/li>\n<li style=\"text-align: justify;\">The injectable version, called Leqembi IQLIK, can cause reactions at the injection area, including \u200bredness, swelling, rash, pain \u200bor bruising, \u2060the Food and Drug Administration said.<\/li>\n<li style=\"text-align: justify;\">The FDA&#8217;s decision was based on two earlier trials showing the IV version \u200bof Leqembi was effective in patients with early Alzheimer&#8217;s \u200bdisease, including \u2060those with mild cognitive impairment or mild dementia and confirmed amyloid buildup in the brain.<\/li>\n<li style=\"text-align: justify;\">The regulator said the subcutaneous version was not tested in \u2060separate large \u200btrials measuring patient outcomes. Instead, it relied \u200bon findings showing it produced equivalent results and similar reductions in amyloid plaques compared with \u200bthe infused version.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>FDA approves at-home starter dose of Eisai-Biogen Alzheimer&#8217;s drug The U.S. FDA on Monday approved an at-home starting dose of Eisai&#8217;s\u00a0(4523.T), opens new tab\u00a0and Biogen&#8217;s\u00a0(BIIB.O), opens new tab\u00a0Alzheimer&#8217;s drug, allowing \u200bsome patients to begin therapy with injections administered by themselves \u200cor a caregiver. Shares of Biogen were up 4.5% in afternoon trading. The approval applies [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":2954,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[12],"tags":[974],"class_list":["post-2953","post","type-post","status-publish","format-standard","has-post-thumbnail","category-food-and-drug-organization","tag-fda-approves-at-home-starter-dose-of-eisai-biogen-alzheimers-drug"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v24.1 (Yoast SEO v24.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA approves at-home starter dose of Eisai-Biogen Alzheimer&#039;s drug - whmnews<\/title>\n<meta name=\"description\" content=\"FDA approves at-home starter dose of Eisai-Biogen Alzheimer&#039;s drug\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/whmnews.ir\/En\/index.php\/2026\/07\/14\/fda-approves-at-home-starter-dose-of-eisai-biogen-alzheimers-drug\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA approves at-home starter dose of Eisai-Biogen Alzheimer&#039;s drug\" \/>\n<meta property=\"og:description\" content=\"FDA approves at-home starter dose of Eisai-Biogen Alzheimer&#039;s drug\" \/>\n<meta property=\"og:url\" content=\"https:\/\/whmnews.ir\/En\/index.php\/2026\/07\/14\/fda-approves-at-home-starter-dose-of-eisai-biogen-alzheimers-drug\/\" \/>\n<meta property=\"og:site_name\" content=\"whmnews\" \/>\n<meta property=\"article:published_time\" content=\"2026-07-14T06:32:27+00:00\" \/>\n<meta property=\"og:image\" content=\"http:\/\/whmnews.ir\/En\/wp-content\/uploads\/2026\/07\/FDA-approves-at-home-starter-dose-of-Eisai-Biogen-Alzheimers-drug.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"975\" \/>\n\t<meta property=\"og:image:height\" content=\"547\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Roza News\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Roza News\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/whmnews.ir\/En\/index.php\/2026\/07\/14\/fda-approves-at-home-starter-dose-of-eisai-biogen-alzheimers-drug\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/whmnews.ir\/En\/index.php\/2026\/07\/14\/fda-approves-at-home-starter-dose-of-eisai-biogen-alzheimers-drug\/\"},\"author\":{\"name\":\"Roza News\",\"@id\":\"https:\/\/whmnews.ir\/En\/#\/schema\/person\/77fef232f03e0a43eb2c2ecc12e4de2e\"},\"headline\":\"FDA approves at-home starter dose of Eisai-Biogen Alzheimer&#8217;s drug\",\"datePublished\":\"2026-07-14T06:32:27+00:00\",\"dateModified\":\"2026-07-14T06:32:27+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/whmnews.ir\/En\/index.php\/2026\/07\/14\/fda-approves-at-home-starter-dose-of-eisai-biogen-alzheimers-drug\/\"},\"wordCount\":322,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/whmnews.ir\/En\/#organization\"},\"image\":{\"@id\":\"https:\/\/whmnews.ir\/En\/index.php\/2026\/07\/14\/fda-approves-at-home-starter-dose-of-eisai-biogen-alzheimers-drug\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/whmnews.ir\/En\/wp-content\/uploads\/2026\/07\/FDA-approves-at-home-starter-dose-of-Eisai-Biogen-Alzheimers-drug.jpg\",\"keywords\":[\"FDA approves at-home starter dose of Eisai-Biogen Alzheimer's drug\"],\"articleSection\":[\"Food and Drug Organization\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/whmnews.ir\/En\/index.php\/2026\/07\/14\/fda-approves-at-home-starter-dose-of-eisai-biogen-alzheimers-drug\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/whmnews.ir\/En\/index.php\/2026\/07\/14\/fda-approves-at-home-starter-dose-of-eisai-biogen-alzheimers-drug\/\",\"url\":\"https:\/\/whmnews.ir\/En\/index.php\/2026\/07\/14\/fda-approves-at-home-starter-dose-of-eisai-biogen-alzheimers-drug\/\",\"name\":\"FDA approves at-home starter dose of Eisai-Biogen Alzheimer's drug - 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