{"id":67920,"date":"2026-06-10T21:01:19","date_gmt":"2026-06-10T13:01:19","guid":{"rendered":"https:\/\/flcube.com\/?p=67920"},"modified":"2026-06-10T21:01:21","modified_gmt":"2026-06-10T13:01:21","slug":"takedas-entyvio-receives-fda-acceptance-for-pediatric-sbla-in-ulcerative-colitis-and-crohns-disease-expanding-gut-selective-biologic-to-patients-aged-2","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=67920","title":{"rendered":"Takeda&#8217;s Entyvio Receives FDA Acceptance for Pediatric sBLA in Ulcerative Colitis and Crohn&#8217;s Disease, Expanding Gut-Selective Biologic to Patients Aged 2+"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Takeda Pharmaceutical Company Limited<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/4502:TYO\">TYO: 4502<\/a>; <a href=\"https:\/\/www.google.com\/finance\/quote\/TAK:NYSE\">NYSE: TAK<\/a>) announced that the <strong>U.S. Food and Drug Administration (FDA)<\/strong> has accepted for review a <strong>supplemental Biologics License Application (sBLA)<\/strong> for <strong>Entyvio\u00ae (vedolizumab) intravenous (IV) formulation<\/strong> for the treatment of <strong>pediatric patients aged 2 years and older<\/strong> with <strong>moderately to severely active ulcerative colitis (UC) and Crohn&#8217;s disease<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Entyvio is currently the <strong>only gut-selective biologic therapy<\/strong> approved for adults with UC and Crohn&#8217;s disease, specifically binding to <strong>\u03b14\u03b27 integrin<\/strong> and blocking its interaction with <strong>MAdCAM-1<\/strong>, which is predominantly expressed on gut endothelial cells. This targeted mechanism minimizes systemic immunosuppression while providing focused anti-inflammatory activity in the gastrointestinal tract.<\/p>\n\n\n\n<h2 id=\"h-regulatory-status-amp-global-approvals\" class=\"wp-block-heading\">Regulatory Status &amp; Global Approvals<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Product Formulation<\/th><th>Current Indications<\/th><th>Global Approval Status<\/th><\/tr><\/thead><tbody><tr><td><strong>Entyvio IV<\/strong><\/td><td>Adult UC and Crohn&#8217;s disease<\/td><td>Approved in <strong>80+ countries<\/strong><\/td><\/tr><tr><td><strong>Entyvio SC<\/strong><\/td><td>Adult UC and Crohn&#8217;s disease<\/td><td>Approved in <strong>50+ countries<\/strong><\/td><\/tr><tr><td><strong>Entyvio IV (Pediatric)<\/strong><\/td><td>Under FDA review (ages 2+)<\/td><td>Potential first gut-selective biologic for pediatric IBD<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 id=\"h-current-adult-indication-details\" class=\"wp-block-heading\">Current Adult Indication Details<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Patient Population<\/strong>: Adults with moderately to severely active UC and Crohn&#8217;s disease<\/li>\n\n\n\n<li><strong>Treatment History<\/strong>: Inadequate response, loss of response, or intolerance to conventional therapies or TNF-\u03b1 antagonists<\/li>\n\n\n\n<li><strong>Administration Options<\/strong>: Both IV and subcutaneous formulations available<\/li>\n\n\n\n<li><strong>Mechanism<\/strong>: Gut-selective \u03b14\u03b27 integrin inhibition<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-clinical-significance-amp-market-opportunity\" class=\"wp-block-heading\">Clinical Significance &amp; Market Opportunity<\/h2>\n\n\n\n<h3 id=\"h-pediatric-inflammatory-bowel-disease-landscape\" class=\"wp-block-heading\">Pediatric Inflammatory Bowel Disease Landscape<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Unmet Need<\/strong>: Limited biologic options specifically approved for young pediatric patients<\/li>\n\n\n\n<li><strong>Current Treatment Gaps<\/strong>: Most existing biologics lack formal pediatric indications below age 6-12<\/li>\n\n\n\n<li><strong>Safety Profile<\/strong>: Gut-selective mechanism potentially offers improved safety compared to systemic immunosuppressants<\/li>\n\n\n\n<li><strong>Dosing Flexibility<\/strong>: IV formulation suitable for very young patients who may not tolerate subcutaneous administration<\/li>\n<\/ul>\n\n\n\n<h3 id=\"h-competitive-differentiation\" class=\"wp-block-heading\">Competitive Differentiation<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Gut Selectivity<\/strong>: Only biologic with exclusive gastrointestinal targeting mechanism<\/li>\n\n\n\n<li><strong>Systemic Safety<\/strong>: Reduced risk of systemic infections compared to TNF inhibitors and other systemic biologics<\/li>\n\n\n\n<li><strong>Pediatric Expansion<\/strong>: Potential to become first-line biologic option for young IBD patients<\/li>\n\n\n\n<li><strong>Franchise Extension<\/strong>: Leverages established adult safety and efficacy data for pediatric indication<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-commercial-implications-amp-revenue-outlook\" class=\"wp-block-heading\">Commercial Implications &amp; Revenue Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Market Size<\/strong>: Estimated 60,000-80,000 pediatric IBD patients in the U.S. aged 2-17 years<\/li>\n\n\n\n<li><strong>Pricing Strategy<\/strong>: Premium positioning based on targeted mechanism and pediatric exclusivity potential<\/li>\n\n\n\n<li><strong>Revenue Contribution<\/strong>: Analysts project $200-300 million in peak annual pediatric sales globally<\/li>\n\n\n\n<li><strong>Franchise Protection<\/strong>: Extends Entyvio&#8217;s market leadership as biosimilar competition emerges in adult indications<\/li>\n\n\n\n<li><strong>Launch Timeline<\/strong>: Potential approval by Q2 2027 based on standard 10-month FDA review cycle<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">This sBLA acceptance represents a significant expansion of Entyvio&#8217;s addressable market and reinforces Takeda&#8217;s commitment to addressing unmet needs across the full spectrum of inflammatory bowel disease patients, from young children to adults.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward-Looking Statements<\/strong><br>This brief contains forward-looking statements regarding regulatory timelines, market opportunities, competitive dynamics, and revenue projections. Actual results may differ due to regulatory decisions, market adoption rates, and competitive pressures.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that the U.S. Food and Drug&#8230;<\/p>\n","protected":false},"author":1,"featured_media":67924,"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":[874,345,1141],"class_list":["post-67920","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-nyse-tak","tag-takeda","tag-tyo-4502"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Takeda&#039;s Entyvio Receives FDA Acceptance for Pediatric sBLA in Ulcerative Colitis and Crohn&#039;s Disease, Expanding Gut-Selective Biologic to Patients Aged 2+ - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for Entyvio\u00ae (vedolizumab) intravenous (IV) formulation for the treatment of pediatric patients aged 2 years and older with moderately to severely active ulcerative colitis (UC) and Crohn&#039;s disease.\" \/>\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=67920\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Takeda&#039;s Entyvio Receives FDA Acceptance for Pediatric sBLA in Ulcerative Colitis and Crohn&#039;s Disease, Expanding Gut-Selective Biologic to Patients Aged 2+\" \/>\n<meta property=\"og:description\" content=\"Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for Entyvio\u00ae (vedolizumab) intravenous (IV) formulation for the treatment of pediatric patients aged 2 years and older with moderately to severely active ulcerative colitis (UC) and Crohn&#039;s disease.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=67920\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2026-06-10T13:01:19+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-06-10T13:01:21+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2026\/06\/1001-1.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=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=67920#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=67920\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Takeda&#8217;s Entyvio Receives FDA Acceptance for Pediatric sBLA in Ulcerative Colitis and Crohn&#8217;s Disease, Expanding Gut-Selective Biologic to Patients Aged 2+\",\"datePublished\":\"2026-06-10T13:01:19+00:00\",\"dateModified\":\"2026-06-10T13:01:21+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=67920\"},\"wordCount\":470,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=67920#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/1001-1.webp\",\"keywords\":[\"NYSE: TAK\",\"Takeda\",\"TYO: 4502\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=67920#respond\"]}],\"copyrightYear\":\"2026\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=67920\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=67920\",\"name\":\"Takeda's Entyvio Receives FDA Acceptance for Pediatric sBLA in Ulcerative Colitis and Crohn's Disease, Expanding Gut-Selective Biologic to Patients Aged 2+ - Insight, China&#039;s Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=67920#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=67920#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/1001-1.webp\",\"datePublished\":\"2026-06-10T13:01:19+00:00\",\"dateModified\":\"2026-06-10T13:01:21+00:00\",\"description\":\"Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for Entyvio\u00ae (vedolizumab) intravenous (IV) formulation for the treatment of pediatric patients aged 2 years and older with moderately to severely active ulcerative colitis (UC) and Crohn's disease.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=67920#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=67920\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=67920#primaryimage\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/1001-1.webp\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2026\\\/06\\\/1001-1.webp\",\"width\":1080,\"height\":608,\"caption\":\"Takeda's Entyvio Receives FDA Acceptance for Pediatric sBLA in Ulcerative Colitis and Crohn's Disease, Expanding Gut-Selective Biologic to Patients Aged 2+\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=67920#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Takeda&#8217;s Entyvio Receives FDA Acceptance for Pediatric sBLA in Ulcerative Colitis and Crohn&#8217;s Disease, Expanding Gut-Selective Biologic to Patients Aged 2+\"}]},{\"@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":"Takeda's Entyvio Receives FDA Acceptance for Pediatric sBLA in Ulcerative Colitis and Crohn's Disease, Expanding Gut-Selective Biologic to Patients Aged 2+ - Insight, China&#039;s Pharmaceutical Industry","description":"Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for Entyvio\u00ae (vedolizumab) intravenous (IV) formulation for the treatment of pediatric patients aged 2 years and older with moderately to severely active ulcerative colitis (UC) and Crohn's disease.","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=67920","og_locale":"en_US","og_type":"article","og_title":"Takeda's Entyvio Receives FDA Acceptance for Pediatric sBLA in Ulcerative Colitis and Crohn's Disease, Expanding Gut-Selective Biologic to Patients Aged 2+","og_description":"Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for Entyvio\u00ae (vedolizumab) intravenous (IV) formulation for the treatment of pediatric patients aged 2 years and older with moderately to severely active ulcerative colitis (UC) and Crohn's disease.","og_url":"https:\/\/flcube.com\/?p=67920","og_site_name":"Insight, China&#039;s Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2026-06-10T13:01:19+00:00","article_modified_time":"2026-06-10T13:01:21+00:00","og_image":[{"width":1080,"height":608,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/06\/1001-1.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":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=67920#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=67920"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Takeda&#8217;s Entyvio Receives FDA Acceptance for Pediatric sBLA in Ulcerative Colitis and Crohn&#8217;s Disease, Expanding Gut-Selective Biologic to Patients Aged 2+","datePublished":"2026-06-10T13:01:19+00:00","dateModified":"2026-06-10T13:01:21+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=67920"},"wordCount":470,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"image":{"@id":"https:\/\/flcube.com\/?p=67920#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/06\/1001-1.webp","keywords":["NYSE: TAK","Takeda","TYO: 4502"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=67920#respond"]}],"copyrightYear":"2026","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=67920","url":"https:\/\/flcube.com\/?p=67920","name":"Takeda's Entyvio Receives FDA Acceptance for Pediatric sBLA in Ulcerative Colitis and Crohn's Disease, Expanding Gut-Selective Biologic to Patients Aged 2+ - Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/flcube.com\/?p=67920#primaryimage"},"image":{"@id":"https:\/\/flcube.com\/?p=67920#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/06\/1001-1.webp","datePublished":"2026-06-10T13:01:19+00:00","dateModified":"2026-06-10T13:01:21+00:00","description":"Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for Entyvio\u00ae (vedolizumab) intravenous (IV) formulation for the treatment of pediatric patients aged 2 years and older with moderately to severely active ulcerative colitis (UC) and Crohn's disease.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=67920#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=67920"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=67920#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/06\/1001-1.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2026\/06\/1001-1.webp","width":1080,"height":608,"caption":"Takeda's Entyvio Receives FDA Acceptance for Pediatric sBLA in Ulcerative Colitis and Crohn's Disease, Expanding Gut-Selective Biologic to Patients Aged 2+"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=67920#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Takeda&#8217;s Entyvio Receives FDA Acceptance for Pediatric sBLA in Ulcerative Colitis and Crohn&#8217;s Disease, Expanding Gut-Selective Biologic to Patients Aged 2+"}]},{"@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\/2026\/06\/1001-1.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/67920","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=67920"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/67920\/revisions"}],"predecessor-version":[{"id":67925,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/67920\/revisions\/67925"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/67924"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=67920"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=67920"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=67920"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}