{"id":30979,"date":"2025-03-31T17:27:28","date_gmt":"2025-03-31T09:27:28","guid":{"rendered":"https:\/\/flcube.com\/?p=30979"},"modified":"2025-03-31T17:27:29","modified_gmt":"2025-03-31T09:27:29","slug":"emas-chmp-issues-negative-opinion-on-lillys-kisunla-for-alzheimers","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=30979","title":{"rendered":"EMA’s CHMP Issues Negative Opinion on Lilly’s Kisunla for Alzheimer’s"},"content":{"rendered":"\n

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion last week regarding the approval of Eli Lilly and Company’s (NYSE: LLY<\/a>) Kisunla (donanemab) for the treatment of early Alzheimer’s disease (AD). Despite this setback, the US pharmaceutical giant stated that it will seek a review from the CHMP and expressed confidence in the safety and efficacy of donanemab.<\/p>\n\n\n\n

Donanemab’s Unique Profile<\/strong>
Donanemab is the world\u2019s third anti-amyloid therapy following Biogen\/Eisai\u2019s aducanumab (now discontinued) and Eisai\u2019s Leqembi (lecanemab). A distinctive feature of donanemab is that it can be discontinued when PET imaging indicates that amyloid plaques have been reduced to the lowest level. This sets it apart from the other two therapies, which do not offer the same flexibility.<\/p>\n\n\n\n

Global Approval Status<\/strong>
Kisunla has already secured marketing approvals in the US, Japan, and China in July, September, and December of last year, respectively. These approvals highlight the drug\u2019s recognized potential in addressing the unmet needs of Alzheimer\u2019s patients outside the European market.<\/p>\n\n\n\n

Lilly’s Response<\/strong>
Eli Lilly remains committed to advancing donanemab as a treatment option for Alzheimer\u2019s disease and is actively pursuing a review of the CHMP\u2019s decision. The company\u2019s confidence in the therapy is based on extensive clinical data demonstrating its positive impact on patients.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)…<\/p>\n","protected":false},"author":1,"featured_media":30980,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[351,350,199,911],"class_list":["post-30979","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-biogen","tag-eisai","tag-eli-lilly","tag-nyse-lly"],"yoast_head":"\nEMA's CHMP Issues Negative Opinion on Lilly's Kisunla for Alzheimer's - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion last week regarding the approval of Eli Lilly and Company's (NYSE: LLY) Kisunla (donanemab) for the treatment of early Alzheimer's disease (AD). Despite this setback, the US pharmaceutical giant stated that it will seek a review from the CHMP and expressed confidence in the safety and efficacy of donanemab.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=30979\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EMA's CHMP Issues Negative Opinion on Lilly's Kisunla for Alzheimer's\" \/>\n<meta property=\"og:description\" content=\"The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion last week regarding the approval of Eli Lilly and Company's (NYSE: LLY) Kisunla (donanemab) for the treatment of early Alzheimer's disease (AD). Despite this setback, the US pharmaceutical giant stated that it will seek a review from the CHMP and expressed confidence in the safety and efficacy of donanemab.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=30979\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China's Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2025-03-31T09:27:28+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-03-31T09:27:29+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/03\/3118-png.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Fineline Cube\" \/>\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:\\\/\\\/flcube.com\\\/?p=30979#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=30979\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"EMA’s CHMP Issues Negative Opinion on Lilly’s Kisunla for Alzheimer’s\",\"datePublished\":\"2025-03-31T09:27:28+00:00\",\"dateModified\":\"2025-03-31T09:27:29+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=30979\"},\"wordCount\":245,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=30979#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/03\\\/3118-png.webp\",\"keywords\":[\"Biogen\",\"Eisai\",\"Eli Lilly\",\"NYSE: LLY\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=30979#respond\"]}],\"copyrightYear\":\"2025\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=30979\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=30979\",\"name\":\"EMA's CHMP Issues Negative Opinion on Lilly's Kisunla for Alzheimer's - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=30979#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=30979#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/03\\\/3118-png.webp\",\"datePublished\":\"2025-03-31T09:27:28+00:00\",\"dateModified\":\"2025-03-31T09:27:29+00:00\",\"description\":\"The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion last week regarding the approval of Eli Lilly and Company's (NYSE: LLY) Kisunla (donanemab) for the treatment of early Alzheimer's disease (AD). Despite this setback, the US pharmaceutical giant stated that it will seek a review from the CHMP and expressed confidence in the safety and efficacy of donanemab.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=30979#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=30979\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=30979#primaryimage\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/03\\\/3118-png.webp\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/03\\\/3118-png.webp\",\"width\":1080,\"height\":608,\"caption\":\"EMA's CHMP Issues Negative Opinion on Lilly's Kisunla for Alzheimer's\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=30979#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"EMA’s CHMP Issues Negative Opinion on Lilly’s Kisunla for Alzheimer’s\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"name\":\"Insight, China's Pharmaceutical Industry\",\"description\":\"Fineline Insights, Pharma Clarity\",\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/flcube.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\",\"name\":\"Fineline Infomation and Technology\",\"alternateName\":\"Fineline Info & Tech\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"width\":2560,\"height\":1894,\"caption\":\"Fineline Infomation and Technology\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/profile.php?id=61566606313834\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\",\"name\":\"Fineline Cube\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"caption\":\"Fineline Cube\"},\"sameAs\":[\"https:\\\/\\\/flcube.com\"],\"url\":\"https:\\\/\\\/flcube.com\\\/?author=1\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"EMA's CHMP Issues Negative Opinion on Lilly's Kisunla for Alzheimer's - Insight, China's Pharmaceutical Industry","description":"The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion last week regarding the approval of Eli Lilly and Company's (NYSE: LLY) Kisunla (donanemab) for the treatment of early Alzheimer's disease (AD). Despite this setback, the US pharmaceutical giant stated that it will seek a review from the CHMP and expressed confidence in the safety and efficacy of donanemab.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/flcube.com\/?p=30979","og_locale":"en_US","og_type":"article","og_title":"EMA's CHMP Issues Negative Opinion on Lilly's Kisunla for Alzheimer's","og_description":"The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion last week regarding the approval of Eli Lilly and Company's (NYSE: LLY) Kisunla (donanemab) for the treatment of early Alzheimer's disease (AD). Despite this setback, the US pharmaceutical giant stated that it will seek a review from the CHMP and expressed confidence in the safety and efficacy of donanemab.","og_url":"https:\/\/flcube.com\/?p=30979","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2025-03-31T09:27:28+00:00","article_modified_time":"2025-03-31T09:27:29+00:00","og_image":[{"width":1080,"height":608,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/03\/3118-png.webp","type":"image\/png"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_description":"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=30979#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=30979"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"EMA’s CHMP Issues Negative Opinion on Lilly’s Kisunla for Alzheimer’s","datePublished":"2025-03-31T09:27:28+00:00","dateModified":"2025-03-31T09:27:29+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=30979"},"wordCount":245,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"image":{"@id":"https:\/\/flcube.com\/?p=30979#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/03\/3118-png.webp","keywords":["Biogen","Eisai","Eli Lilly","NYSE: LLY"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=30979#respond"]}],"copyrightYear":"2025","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=30979","url":"https:\/\/flcube.com\/?p=30979","name":"EMA's CHMP Issues Negative Opinion on Lilly's Kisunla for Alzheimer's - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/flcube.com\/?p=30979#primaryimage"},"image":{"@id":"https:\/\/flcube.com\/?p=30979#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/03\/3118-png.webp","datePublished":"2025-03-31T09:27:28+00:00","dateModified":"2025-03-31T09:27:29+00:00","description":"The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion last week regarding the approval of Eli Lilly and Company's (NYSE: LLY) Kisunla (donanemab) for the treatment of early Alzheimer's disease (AD). Despite this setback, the US pharmaceutical giant stated that it will seek a review from the CHMP and expressed confidence in the safety and efficacy of donanemab.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=30979#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=30979"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=30979#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/03\/3118-png.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/03\/3118-png.webp","width":1080,"height":608,"caption":"EMA's CHMP Issues Negative Opinion on Lilly's Kisunla for Alzheimer's"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=30979#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"EMA’s CHMP Issues Negative Opinion on Lilly’s Kisunla for Alzheimer’s"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/03\/3118-png.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/30979","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=30979"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/30979\/revisions"}],"predecessor-version":[{"id":30981,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/30979\/revisions\/30981"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/30980"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=30979"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=30979"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=30979"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}