{"id":290859,"date":"2025-07-25T14:57:09","date_gmt":"2025-07-25T14:57:09","guid":{"rendered":"https:\/\/www.europesays.com\/uk\/290859\/"},"modified":"2025-07-25T14:57:09","modified_gmt":"2025-07-25T14:57:09","slug":"eu-regulator-backs-lillys-alzheimers-drug-politico","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/uk\/290859\/","title":{"rendered":"EU regulator backs Lilly\u2019s Alzheimer\u2019s drug \u2013 POLITICO"},"content":{"rendered":"<p>The European Medicines Agency has <a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/medicine-qa\/questions-answers-approval-marketing-authorisation-kisunla-donanemab-outcome-re-examination_en.pdf\" target=\"_blank\" rel=\"noopener\">granted<\/a> restricted EU authorization to Eli Lilly\u2019s Alzheimer\u2019s drug Kisunla, reversing an earlier decision to reject the drug over concerns that its benefits don\u2019t outweigh the risk of brain swelling or bleeding.<\/p>\n<p>The treatment for early Alzheimer\u2019s disease, which is administered via a monthly infusion, has already been approved in the United States, the United Kingdom, Japan and China. In March, the EMA&#8217;s human medicines committee CHMP rejected the drug\u00a0<a href=\"https:\/\/pro.politico.eu\/press\/211948\" target=\"_blank\" rel=\"noreferrer noopener\">saying<\/a> there was a risk of \u201cpotentially fatal events due to amyloid-related imaging abnormalities (ARIA).\u201d<\/p>\n<p>But on Thursday, after re-examining the drug at the request of Lilly, the CHMP <a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/medicine-qa\/questions-answers-approval-marketing-authorisation-kisunla-donanemab-outcome-re-examination_en.pdf\" target=\"_blank\" rel=\"noopener\">recommended<\/a> granting Kisunla marketing authorization for patients who do not have a copy or only have one copy of the ApoE4 gene, a gene that puts them at a greater risk of Alzheimer\u2019s disease.<\/p>\n","protected":false},"excerpt":{"rendered":"The European Medicines Agency has granted restricted EU authorization to Eli Lilly\u2019s Alzheimer\u2019s drug Kisunla, reversing an earlier&hellip;\n","protected":false},"author":2,"featured_media":290860,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5174],"tags":[1395,2000,299,5187,2122,5769,391,6738,15,49],"class_list":{"0":"post-290859","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-eu","8":"tag-china","9":"tag-eu","10":"tag-europe","11":"tag-european","12":"tag-japan","13":"tag-medicines","14":"tag-opinion","15":"tag-patients","16":"tag-united-kingdom","17":"tag-united-states"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@uk\/114914462673015591","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/290859","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/comments?post=290859"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/290859\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media\/290860"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media?parent=290859"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/categories?post=290859"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/tags?post=290859"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}