{"id":38549,"date":"2025-11-19T20:14:41","date_gmt":"2025-11-19T19:14:41","guid":{"rendered":"https:\/\/sma.selfempowered.net\/?p=38549"},"modified":"2026-03-16T21:04:50","modified_gmt":"2026-03-16T20:04:50","slug":"spinraza-in-hoeherer-dosis-scheint-auf-einem-guten-weg","status":"publish","type":"post","link":"https:\/\/smartunity.space\/stories\/thema\/spinraza-in-hoeherer-dosis-scheint-auf-einem-guten-weg\/","title":{"rendered":"Spinraza in h\u00f6herer Dosis scheint auf einem guten Weg"},"content":{"rendered":"\n<p>Wie im Pressrelease vom 17.11.2025 von Biogen\u00ae bekanntgegeben, gab das CHMP (<a href=\"https:\/\/www.bfarm.de\/DE\/Das-BfArM\/EU-und-Internationales\/CHMP-Ausschuss\/_node.html\">Committee for Medicinal Products for Human Use<\/a>) ein positives Statement zur Zulassung von Nusinersen (Spinraza\u00ae) in h\u00f6herer Dosierung, als die 12mg zur Erstzulassung in 2017 ab.<\/p>\n\n\n\n<p>Grundlage der positiven Stellungnahme sind die Daten der DEVOTE Studie, deren Ergebnisse motorische Verbesserungen anhand diverser Messmethoden aufzeigten.<\/p>\n\n\n\n<p>Laut Mitteilung ist mit einer entg\u00fcltigen Entscheidung im Januar 2026 zu rechnen.<\/p>\n\n\n\n<p><em>Quelle<\/em>: <a href=\"https:\/\/investors.biogen.com\/news-releases\/news-release-details\/high-dose-regimen-nusinersen-receives-positive-chmp-opinion\">Biogen Pressrelease<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Wie im Pressrelease vom 17.11.2025 von Biogen\u00ae bekanntgegeben, gab das CHMP (Committee for Medicinal Products for Human Use) ein positives Statement zur Zulassung von Nusinersen (Spinraza\u00ae) in h\u00f6herer Dosierung, als die 12mg zur Erstzulassung in 2017 ab. Grundlage der positiven Stellungnahme sind die Daten der DEVOTE Studie, deren Ergebnisse motorische Verbesserungen anhand diverser Messmethoden aufzeigten. [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"only-view","format":"standard","meta":{"activitypub_content_warning":"","activitypub_content_visibility":"","activitypub_max_image_attachments":0,"activitypub_interaction_policy_quote":"anyone","activitypub_status":"","footnotes":""},"categories":[1],"tags":[58],"class_list":["post-38549","post","type-post","status-publish","format-standard","hentry","category-thema","tag-smanews"],"_links":{"self":[{"href":"https:\/\/smartunity.space\/stories\/wp-json\/wp\/v2\/posts\/38549","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/smartunity.space\/stories\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/smartunity.space\/stories\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/smartunity.space\/stories\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/smartunity.space\/stories\/wp-json\/wp\/v2\/comments?post=38549"}],"version-history":[{"count":1,"href":"https:\/\/smartunity.space\/stories\/wp-json\/wp\/v2\/posts\/38549\/revisions"}],"predecessor-version":[{"id":39746,"href":"https:\/\/smartunity.space\/stories\/wp-json\/wp\/v2\/posts\/38549\/revisions\/39746"}],"wp:attachment":[{"href":"https:\/\/smartunity.space\/stories\/wp-json\/wp\/v2\/media?parent=38549"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/smartunity.space\/stories\/wp-json\/wp\/v2\/categories?post=38549"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/smartunity.space\/stories\/wp-json\/wp\/v2\/tags?post=38549"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}