{"id":33017,"date":"2025-05-08T14:51:48","date_gmt":"2025-05-08T06:51:48","guid":{"rendered":"https:\/\/flcube.com\/?p=33017"},"modified":"2025-05-08T14:51:49","modified_gmt":"2025-05-08T06:51:49","slug":"european-commission-approves-jjs-tremfya-for-crohns-disease-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=33017","title":{"rendered":"European Commission Approves J&J’s Tremfya for Crohn’s Disease Treatment"},"content":{"rendered":"\n

Johnson & Johnson (J&J, NYSE: JNJ<\/a>) announced that the European Commission (EC) has approved Tremfya (guselkumab) for treating adults with moderately to severely active Crohn’s disease (CD). The approval includes patients who have had an inadequate response, lost response, or were intolerant to conventional therapy or biologic treatments. This decision covers both intravenous (IV) and subcutaneous (SC) induction regimens.<\/p>\n\n\n\n

Clinical Trial Backing<\/strong>
The EC’s approval is supported by positive results from the Phase III GALAXI and GRAVITI trials. The pooled analysis of the GALAXI 2\/3 studies showed that, at Week 48, guselkumab demonstrated superior efficacy compared to ustekinumab in terms of endoscopic response and remission rates. This makes Tremfya the first IL-23 inhibitor to achieve this milestone in a double-blind registrational study. The GRAVITI trial confirmed significant clinical and endoscopic efficacy after 12-week induction and 48-week maintenance, whether administered via IV or SC.<\/p>\n\n\n\n

Guselkumab’s Regulatory Milestones<\/strong>
Guselkumab is the first fully human, dual-mechanism IL-23 inhibitor to receive approval. Its regulatory milestones in the EU include initial approval for moderate-to-severe plaque psoriasis in adults eligible for systemic therapy in November 2017, expanded approval for active psoriatic arthritis in adults with inadequate response to prior disease-modifying antirheumatic drugs (DMARDs) in November 2020, and approval for moderate-to-severe active ulcerative colitis (UC) in adults unresponsive to conventional or biologic therapies in April 2025.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission (EC) has approved Tremfya…<\/p>\n","protected":false},"author":1,"featured_media":33018,"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":[150,149,858,15],"class_list":["post-33017","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-jj","tag-johnson-johnson","tag-nyse-jnj","tag-product-approvals"],"yoast_head":"\nEuropean Commission Approves J&J's Tremfya for Crohn's Disease Treatment - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission (EC) has approved Tremfya (guselkumab) for treating adults with moderately to severely active Crohn's disease (CD). The approval includes patients who have had an inadequate response, lost response, or were intolerant to conventional therapy or biologic treatments. This decision covers both intravenous (IV) and subcutaneous (SC) induction regimens.\" \/>\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=33017\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"European Commission Approves J&J's Tremfya for Crohn's Disease Treatment\" \/>\n<meta property=\"og:description\" content=\"Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission (EC) has approved Tremfya (guselkumab) for treating adults with moderately to severely active Crohn's disease (CD). The approval includes patients who have had an inadequate response, lost response, or were intolerant to conventional therapy or biologic treatments. This decision covers both intravenous (IV) and subcutaneous (SC) induction regimens.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=33017\" \/>\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=\"2025-05-08T06:51:48+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-05-08T06:51:49+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/0805.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=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=33017#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=33017\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"European Commission Approves J&J’s Tremfya for Crohn’s Disease Treatment\",\"datePublished\":\"2025-05-08T06:51:48+00:00\",\"dateModified\":\"2025-05-08T06:51:49+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=33017\"},\"wordCount\":236,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=33017#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/05\\\/0805.webp\",\"keywords\":[\"J&J\",\"Johnson & Johnson\",\"NYSE: JNJ\",\"Product approvals\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=33017#respond\"]}],\"copyrightYear\":\"2025\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=33017\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=33017\",\"name\":\"European Commission Approves J&J's Tremfya for Crohn's Disease Treatment - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=33017#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=33017#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/05\\\/0805.webp\",\"datePublished\":\"2025-05-08T06:51:48+00:00\",\"dateModified\":\"2025-05-08T06:51:49+00:00\",\"description\":\"Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission (EC) has approved Tremfya (guselkumab) for treating adults with moderately to severely active Crohn's disease (CD). The approval includes patients who have had an inadequate response, lost response, or were intolerant to conventional therapy or biologic treatments. This decision covers both intravenous (IV) and subcutaneous (SC) induction regimens.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=33017#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=33017\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=33017#primaryimage\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/05\\\/0805.webp\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/05\\\/0805.webp\",\"width\":1080,\"height\":608,\"caption\":\"European Commission Approves J&J's Tremfya for Crohn's Disease Treatment\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=33017#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"European Commission Approves J&J’s Tremfya for Crohn’s Disease Treatment\"}]},{\"@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":"European Commission Approves J&J's Tremfya for Crohn's Disease Treatment - Insight, China's Pharmaceutical Industry","description":"Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission (EC) has approved Tremfya (guselkumab) for treating adults with moderately to severely active Crohn's disease (CD). The approval includes patients who have had an inadequate response, lost response, or were intolerant to conventional therapy or biologic treatments. This decision covers both intravenous (IV) and subcutaneous (SC) induction regimens.","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=33017","og_locale":"en_US","og_type":"article","og_title":"European Commission Approves J&J's Tremfya for Crohn's Disease Treatment","og_description":"Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission (EC) has approved Tremfya (guselkumab) for treating adults with moderately to severely active Crohn's disease (CD). The approval includes patients who have had an inadequate response, lost response, or were intolerant to conventional therapy or biologic treatments. This decision covers both intravenous (IV) and subcutaneous (SC) induction regimens.","og_url":"https:\/\/flcube.com\/?p=33017","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2025-05-08T06:51:48+00:00","article_modified_time":"2025-05-08T06:51:49+00:00","og_image":[{"width":1080,"height":608,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/0805.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":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=33017#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=33017"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"European Commission Approves J&J’s Tremfya for Crohn’s Disease Treatment","datePublished":"2025-05-08T06:51:48+00:00","dateModified":"2025-05-08T06:51:49+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=33017"},"wordCount":236,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"image":{"@id":"https:\/\/flcube.com\/?p=33017#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/0805.webp","keywords":["J&J","Johnson & Johnson","NYSE: JNJ","Product approvals"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=33017#respond"]}],"copyrightYear":"2025","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=33017","url":"https:\/\/flcube.com\/?p=33017","name":"European Commission Approves J&J's Tremfya for Crohn's Disease Treatment - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/flcube.com\/?p=33017#primaryimage"},"image":{"@id":"https:\/\/flcube.com\/?p=33017#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/0805.webp","datePublished":"2025-05-08T06:51:48+00:00","dateModified":"2025-05-08T06:51:49+00:00","description":"Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission (EC) has approved Tremfya (guselkumab) for treating adults with moderately to severely active Crohn's disease (CD). The approval includes patients who have had an inadequate response, lost response, or were intolerant to conventional therapy or biologic treatments. This decision covers both intravenous (IV) and subcutaneous (SC) induction regimens.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=33017#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=33017"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=33017#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/0805.webp","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/05\/0805.webp","width":1080,"height":608,"caption":"European Commission Approves J&J's Tremfya for Crohn's Disease Treatment"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=33017#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"European Commission Approves J&J’s Tremfya for Crohn’s Disease Treatment"}]},{"@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\/05\/0805.webp","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/33017","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=33017"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/33017\/revisions"}],"predecessor-version":[{"id":33019,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/33017\/revisions\/33019"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/33018"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=33017"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=33017"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=33017"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}