{"id":26677,"date":"2025-02-13T23:50:01","date_gmt":"2025-02-13T15:50:01","guid":{"rendered":"https:\/\/flcube.com\/?p=26677"},"modified":"2025-02-13T23:50:03","modified_gmt":"2025-02-13T15:50:03","slug":"roches-evrysdi-tablet-approved-by-fda-for-spinal-muscular-atrophy","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=26677","title":{"rendered":"Roche’s Evrysdi Tablet Approved by FDA for Spinal Muscular Atrophy"},"content":{"rendered":"\n

Swiss giant Roche (SWX: ROG<\/a>) has announced that it has received marketing approval from the US FDA for its Evrysdi (risdiplam) tablet. The tablet is approved to treat spinal muscular atrophy (SMA) patients aged 2 months and above and weighing over 20 kilograms (44 pounds).<\/p>\n\n\n\n

Drug Details<\/strong>
Evrysdi is a survival motor neuron 2 (SMN2) pre-mRNA splicing modifier. It is the only non-invasive disease-modifying treatment for SMA, a severe, progressive neuromuscular disease that can be fatal. The drug has been registered in over 100 countries and has benefited more than 16, 000 patients worldwide.<\/p>\n\n\n\n

Approval and Study Results<\/strong>
The approved 5 mg Evrysdi tablet can be swallowed whole or dispersed in water. In a bioequivalence study, it provided comparable exposure to risdiplam to the original oral solution. Previously, the FDA approved Evrysdi powder for oral solution to treat SMA in adults and children.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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

Swiss giant Roche (SWX: ROG) has announced that it has received marketing approval from the…<\/p>\n","protected":false},"author":1,"featured_media":26678,"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":[15,163,939],"class_list":["post-26677","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-product-approvals","tag-roche","tag-swx-rop"],"yoast_head":"\nRoche's Evrysdi Tablet Approved by FDA for Spinal Muscular Atrophy - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Swiss giant Roche (SWX: ROG) has announced that it has received marketing approval from the US FDA for its Evrysdi (risdiplam) tablet. The tablet is approved to treat spinal muscular atrophy (SMA) patients aged 2 months and above and weighing over 20 kilograms (44 pounds).\" \/>\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=26677\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Roche's Evrysdi Tablet Approved by FDA for Spinal Muscular Atrophy\" \/>\n<meta property=\"og:description\" content=\"Swiss giant Roche (SWX: ROG) has announced that it has received marketing approval from the US FDA for its Evrysdi (risdiplam) tablet. The tablet is approved to treat spinal muscular atrophy (SMA) patients aged 2 months and above and weighing over 20 kilograms (44 pounds).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=26677\" \/>\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=\"2025-02-13T15:50:01+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-02-13T15:50:03+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/02\/1312-png.avif\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"564\" \/>\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=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=26677#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=26677\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Roche’s Evrysdi Tablet Approved by FDA for Spinal Muscular Atrophy\",\"datePublished\":\"2025-02-13T15:50:01+00:00\",\"dateModified\":\"2025-02-13T15:50:03+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=26677\"},\"wordCount\":150,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=26677#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/02\\\/1312-png.avif\",\"keywords\":[\"Product approvals\",\"Roche\",\"SWX: ROP\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=26677#respond\"]}],\"copyrightYear\":\"2025\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=26677\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=26677\",\"name\":\"Roche's Evrysdi Tablet Approved by FDA for Spinal Muscular Atrophy - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=26677#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=26677#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/02\\\/1312-png.avif\",\"datePublished\":\"2025-02-13T15:50:01+00:00\",\"dateModified\":\"2025-02-13T15:50:03+00:00\",\"description\":\"Swiss giant Roche (SWX: ROG) has announced that it has received marketing approval from the US FDA for its Evrysdi (risdiplam) tablet. The tablet is approved to treat spinal muscular atrophy (SMA) patients aged 2 months and above and weighing over 20 kilograms (44 pounds).\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=26677#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=26677\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=26677#primaryimage\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/02\\\/1312-png.avif\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/02\\\/1312-png.avif\",\"width\":1080,\"height\":564,\"caption\":\"Roche's Evrysdi Tablet Approved by FDA for Spinal Muscular Atrophy\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=26677#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Roche’s Evrysdi Tablet Approved by FDA for Spinal Muscular Atrophy\"}]},{\"@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":"Roche's Evrysdi Tablet Approved by FDA for Spinal Muscular Atrophy - Insight, China's Pharmaceutical Industry","description":"Swiss giant Roche (SWX: ROG) has announced that it has received marketing approval from the US FDA for its Evrysdi (risdiplam) tablet. The tablet is approved to treat spinal muscular atrophy (SMA) patients aged 2 months and above and weighing over 20 kilograms (44 pounds).","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=26677","og_locale":"en_US","og_type":"article","og_title":"Roche's Evrysdi Tablet Approved by FDA for Spinal Muscular Atrophy","og_description":"Swiss giant Roche (SWX: ROG) has announced that it has received marketing approval from the US FDA for its Evrysdi (risdiplam) tablet. The tablet is approved to treat spinal muscular atrophy (SMA) patients aged 2 months and above and weighing over 20 kilograms (44 pounds).","og_url":"https:\/\/flcube.com\/?p=26677","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2025-02-13T15:50:01+00:00","article_modified_time":"2025-02-13T15:50:03+00:00","og_image":[{"width":1080,"height":564,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/02\/1312-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":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=26677#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=26677"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Roche’s Evrysdi Tablet Approved by FDA for Spinal Muscular Atrophy","datePublished":"2025-02-13T15:50:01+00:00","dateModified":"2025-02-13T15:50:03+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=26677"},"wordCount":150,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"image":{"@id":"https:\/\/flcube.com\/?p=26677#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/02\/1312-png.avif","keywords":["Product approvals","Roche","SWX: ROP"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=26677#respond"]}],"copyrightYear":"2025","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=26677","url":"https:\/\/flcube.com\/?p=26677","name":"Roche's Evrysdi Tablet Approved by FDA for Spinal Muscular Atrophy - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/flcube.com\/?p=26677#primaryimage"},"image":{"@id":"https:\/\/flcube.com\/?p=26677#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/02\/1312-png.avif","datePublished":"2025-02-13T15:50:01+00:00","dateModified":"2025-02-13T15:50:03+00:00","description":"Swiss giant Roche (SWX: ROG) has announced that it has received marketing approval from the US FDA for its Evrysdi (risdiplam) tablet. The tablet is approved to treat spinal muscular atrophy (SMA) patients aged 2 months and above and weighing over 20 kilograms (44 pounds).","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=26677#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=26677"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=26677#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/02\/1312-png.avif","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/02\/1312-png.avif","width":1080,"height":564,"caption":"Roche's Evrysdi Tablet Approved by FDA for Spinal Muscular Atrophy"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=26677#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Roche’s Evrysdi Tablet Approved by FDA for Spinal Muscular Atrophy"}]},{"@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\/02\/1312-png.avif","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/26677","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=26677"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/26677\/revisions"}],"predecessor-version":[{"id":26679,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/26677\/revisions\/26679"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/26678"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=26677"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=26677"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=26677"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}