{"id":22784,"date":"2025-01-24T18:21:29","date_gmt":"2025-01-24T10:21:29","guid":{"rendered":"https:\/\/flcube.com\/?p=22784"},"modified":"2025-01-24T18:21:31","modified_gmt":"2025-01-24T10:21:31","slug":"biogens-higher-dose-spinraza-regimen-under-review-by-fda-and-ema","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=22784","title":{"rendered":"Biogen’s Higher-Dose Spinraza Regimen Under Review by FDA and EMA"},"content":{"rendered":"\n

US-based biopharmaceutical company Biogen (NASDAQ: BIIB<\/a>) has submitted supplemental New Drug Applications (sNDAs) to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a higher-dose regimen of its spinal muscular atrophy (SMA) treatment, Spinraza (nusinersen). The applications are currently under review by both regulatory bodies, with the aim of expanding treatment options for patients with SMA.<\/p>\n\n\n\n

Higher-Dose Regimen Details<\/strong>
The proposed higher-dose regimen of nusinersen includes a more rapid loading phase, with two 50 mg doses administered 14 days apart, followed by a higher maintenance dose of 28 mg every four months. This contrasts with the currently approved regimen, which features a lower maintenance dose of 12 mg. The new dosing schedule is designed to provide more rapid therapeutic effects and sustained benefits for patients with SMA.<\/p>\n\n\n\n

Clinical Study Results<\/strong>
A Phase II\/III study evaluating the safety, tolerability, pharmacokinetics, and efficacy of the higher-dose nusinersen regimen demonstrated promising results. The study showed that the higher-dose treatment rapidly reduced neurofilament levels, a biomarker associated with nerve damage, in patients with different phenotypes of SMA. Importantly, the safety profile of the higher-dose regimen was found to be comparable to that of the currently approved 12 mg treatment regimen, indicating no significant additional risks.<\/p>\n\n\n\n

Implications for SMA Treatment<\/strong>
If approved, the higher-dose regimen of Spinraza could offer enhanced therapeutic benefits for patients with spinal muscular atrophy, potentially improving outcomes and quality of life. The submission to both the FDA and EMA underscores Biogen’s commitment to advancing SMA treatments globally and addressing the evolving needs of patients and healthcare providers.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

US-based biopharmaceutical company Biogen (NASDAQ: BIIB) has submitted supplemental New Drug Applications (sNDAs) to the…<\/p>\n","protected":false},"author":1,"featured_media":22786,"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":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[351,38,24],"class_list":["post-22784","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-biogen","tag-market-approval-filings","tag-rare-orphan-disease-drugs"],"yoast_head":"\nBiogen's Higher-Dose Spinraza Regimen Under Review by FDA and EMA - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"US-based biopharmaceutical company Biogen (Nasdaq: BIIB) has submitted supplemental New Drug Applications (sNDAs) to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a higher-dose regimen of its spinal muscular atrophy (SMA) treatment, Spinraza (nusinersen). The applications are currently under review by both regulatory bodies, with the aim of expanding treatment options for patients with SMA.\" \/>\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=22784\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Biogen's Higher-Dose Spinraza Regimen Under Review by FDA and EMA\" \/>\n<meta property=\"og:description\" content=\"US-based biopharmaceutical company Biogen (NASDAQ: BIIB) has submitted supplemental New Drug Applications (sNDAs) to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a higher-dose regimen of its spinal muscular atrophy (SMA) treatment, Spinraza (nusinersen). The applications are currently under review by both regulatory bodies, with the aim of expanding treatment options for patients with SMA.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=22784\" \/>\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=\"2025-01-24T10:21:29+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-01-24T10:21:31+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/01\/2402-png.avif\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"642\" \/>\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=22784#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=22784\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Biogen’s Higher-Dose Spinraza Regimen Under Review by FDA and EMA\",\"datePublished\":\"2025-01-24T10:21:29+00:00\",\"dateModified\":\"2025-01-24T10:21:31+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=22784\"},\"wordCount\":273,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=22784#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/01\\\/2402-png.avif\",\"keywords\":[\"Biogen\",\"Market approval filings\",\"Rare \\\/ orphan disease drugs\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=22784#respond\"]}],\"copyrightYear\":\"2025\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=22784\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=22784\",\"name\":\"Biogen's Higher-Dose Spinraza Regimen Under Review by FDA and EMA - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=22784#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=22784#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/01\\\/2402-png.avif\",\"datePublished\":\"2025-01-24T10:21:29+00:00\",\"dateModified\":\"2025-01-24T10:21:31+00:00\",\"description\":\"US-based biopharmaceutical company Biogen (Nasdaq: BIIB) has submitted supplemental New Drug Applications (sNDAs) to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a higher-dose regimen of its spinal muscular atrophy (SMA) treatment, Spinraza (nusinersen). The applications are currently under review by both regulatory bodies, with the aim of expanding treatment options for patients with SMA.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=22784#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=22784\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=22784#primaryimage\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/01\\\/2402-png.avif\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/01\\\/2402-png.avif\",\"width\":1080,\"height\":642,\"caption\":\"Biogen's Higher-Dose Spinraza Regimen Under Review by FDA and EMA\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=22784#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Biogen’s Higher-Dose Spinraza Regimen Under Review by FDA and EMA\"}]},{\"@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":"Biogen's Higher-Dose Spinraza Regimen Under Review by FDA and EMA - Insight, China's Pharmaceutical Industry","description":"US-based biopharmaceutical company Biogen (Nasdaq: BIIB) has submitted supplemental New Drug Applications (sNDAs) to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a higher-dose regimen of its spinal muscular atrophy (SMA) treatment, Spinraza (nusinersen). The applications are currently under review by both regulatory bodies, with the aim of expanding treatment options for patients with SMA.","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=22784","og_locale":"en_US","og_type":"article","og_title":"Biogen's Higher-Dose Spinraza Regimen Under Review by FDA and EMA","og_description":"US-based biopharmaceutical company Biogen (NASDAQ: BIIB) has submitted supplemental New Drug Applications (sNDAs) to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a higher-dose regimen of its spinal muscular atrophy (SMA) treatment, Spinraza (nusinersen). The applications are currently under review by both regulatory bodies, with the aim of expanding treatment options for patients with SMA.","og_url":"https:\/\/flcube.com\/?p=22784","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2025-01-24T10:21:29+00:00","article_modified_time":"2025-01-24T10:21:31+00:00","og_image":[{"width":1080,"height":642,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/01\/2402-png.avif","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=22784#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=22784"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Biogen’s Higher-Dose Spinraza Regimen Under Review by FDA and EMA","datePublished":"2025-01-24T10:21:29+00:00","dateModified":"2025-01-24T10:21:31+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=22784"},"wordCount":273,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"image":{"@id":"https:\/\/flcube.com\/?p=22784#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/01\/2402-png.avif","keywords":["Biogen","Market approval filings","Rare \/ orphan disease drugs"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=22784#respond"]}],"copyrightYear":"2025","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=22784","url":"https:\/\/flcube.com\/?p=22784","name":"Biogen's Higher-Dose Spinraza Regimen Under Review by FDA and EMA - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/flcube.com\/?p=22784#primaryimage"},"image":{"@id":"https:\/\/flcube.com\/?p=22784#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/01\/2402-png.avif","datePublished":"2025-01-24T10:21:29+00:00","dateModified":"2025-01-24T10:21:31+00:00","description":"US-based biopharmaceutical company Biogen (Nasdaq: BIIB) has submitted supplemental New Drug Applications (sNDAs) to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a higher-dose regimen of its spinal muscular atrophy (SMA) treatment, Spinraza (nusinersen). The applications are currently under review by both regulatory bodies, with the aim of expanding treatment options for patients with SMA.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=22784#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=22784"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=22784#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/01\/2402-png.avif","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/01\/2402-png.avif","width":1080,"height":642,"caption":"Biogen's Higher-Dose Spinraza Regimen Under Review by FDA and EMA"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=22784#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Biogen’s Higher-Dose Spinraza Regimen Under Review by FDA and EMA"}]},{"@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\/01\/2402-png.avif","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/22784","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=22784"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/22784\/revisions"}],"predecessor-version":[{"id":22787,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/22784\/revisions\/22787"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/22786"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=22784"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=22784"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=22784"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}