{"id":51821,"date":"2025-12-23T12:53:45","date_gmt":"2025-12-23T04:53:45","guid":{"rendered":"https:\/\/flcube.com\/?p=51821"},"modified":"2025-12-23T12:53:46","modified_gmt":"2025-12-23T04:53:46","slug":"jj-tremfya-pediatric-psoriasis-ec-approval-targets-first-il-23-indication","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=51821","title":{"rendered":"J&amp;J TREMFYA Pediatric Psoriasis EC Approval Targets First IL-23 Indication"},"content":{"rendered":"\n<p><strong>Johnson &amp; Johnson<\/strong> (J&amp;J, <a href=\"https:\/\/www.google.com\/finance\/quote\/JNJ:NYSE\">NYSE: JNJ<\/a>) announced that the <strong>European Commission (EC)<\/strong> has extended the marketing authorization for <strong>TREMFYA (guselkumab)<\/strong> as a subcutaneous treatment for <strong>moderate to severe plaque psoriasis<\/strong> in <strong>children and adolescents from age 6 years<\/strong>, making it the <strong>first IL\u201123 inhibitor approved for any pediatric indication<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-milestone-amp-indication\">Regulatory Milestone &amp; Indication<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Attribute<\/th><th>Details<\/th><\/tr><\/thead><tbody><tr><td><strong>Company<\/strong><\/td><td>Johnson &amp; Johnson (NYSE: JNJ)<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>TREMFYA (guselkumab)<\/td><\/tr><tr><td><strong>Regulatory Authority<\/strong><\/td><td>European Commission (EC)<\/td><\/tr><tr><td><strong>Approval Type<\/strong><\/td><td>Marketing authorization extension<\/td><\/tr><tr><td><strong>Indication<\/strong><\/td><td>Moderate to severe plaque psoriasis (Pso) in pediatric patients (\u22656 years)<\/td><\/tr><tr><td><strong>Significance<\/strong><\/td><td><strong>First IL\u201123 inhibitor approved for pediatric use globally<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-clinical-basis-phase-3-protostar-amp-voyage-studies\">Clinical Basis: Phase 3 PROTOSTAR &amp; VOYAGE Studies<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Study<\/th><th>Design<\/th><th>Patient Population<\/th><th>Key Results at Week 16<\/th><\/tr><\/thead><tbody><tr><td><strong>PROTOSTAR<\/strong><\/td><td>Phase\u202f3, randomized, placebo\u2011controlled<\/td><td>120 pediatric patients (6\u201117 years)<\/td><td><strong>PASI 75: 76% vs. 20% placebo (p&lt;0.001)<\/strong><br><strong>IGA 0\/1: 66% vs. 16% placebo (p&lt;0.001)<\/strong><\/td><\/tr><tr><td><strong>VOYAGE 1 &amp; 2<\/strong><\/td><td>Phase\u202f3 (bridging PK data)<\/td><td>Adult patients with moderate to severe plaque Pso<\/td><td>Established pharmacokinetic and safety profile for guselkumab<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-safety-amp-efficacy-highlights\">Safety &amp; Efficacy Highlights<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Primary Endpoints<\/strong>: Both PASI 75 and IGA 0\/1 achieved at Week 16 in PROTOSTAR<\/li>\n\n\n\n<li><strong>Response Rates<\/strong>: Significantly superior to placebo (p&lt;0.001 for both endpoints)<\/li>\n\n\n\n<li><strong>Safety Profile<\/strong>: Consistent with adult population; no new safety signals in pediatric patients<\/li>\n\n\n\n<li><strong>Dosing<\/strong>: Subcutaneous injection regimen identical to adult dosing<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-market-context-amp-strategic-outlook\">Market Context &amp; Strategic Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Psoriasis Burden<\/strong>: <strong>1.5 million<\/strong> pediatric patients globally affected by moderate to severe plaque psoriasis<\/li>\n\n\n\n<li><strong>Unmet Need<\/strong>: Limited biologic options for children; topical therapies often insufficient<\/li>\n\n\n\n<li><strong>Competitive Landscape<\/strong>: TREMFYA is first IL\u201123 inhibitor in pediatric space; competes with <strong>TNF inhibitors<\/strong> and <strong>IL\u201117 inhibitors<\/strong> in adult market<\/li>\n\n\n\n<li><strong>Revenue Impact<\/strong>: Analysts estimate <strong>$500\u2011700 million<\/strong> in additional peak sales from pediatric indication<\/li>\n\n\n\n<li><strong>Launch Timeline<\/strong>: European rollout expected <strong>Q2\u202f2026<\/strong> following pricing and reimbursement discussions<\/li>\n<\/ul>\n\n\n\n<p><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding TREMFYA&#8217;s pediatric commercialization timelines, market penetration, and safety profile. Actual results may differ due to regulatory, competitive, and market access uncertainties.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Johnson &amp; Johnson (J&amp;J, NYSE: JNJ) announced that the European Commission (EC) has extended the&#8230;<\/p>\n","protected":false},"author":1,"featured_media":51824,"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-51821","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":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>J&amp;J TREMFYA Pediatric Psoriasis EC Approval Targets First IL-23 Indication - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Johnson &amp; Johnson (J&amp;J, NYSE: JNJ) announced that the European Commission (EC) has extended the marketing authorization for TREMFYA (guselkumab) as a subcutaneous treatment for moderate to severe plaque psoriasis in children and adolescents from age 6 years, making it the first IL\u201123 inhibitor approved for any pediatric indication.\" \/>\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=51821\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"J&amp;J TREMFYA Pediatric Psoriasis EC Approval Targets First IL-23 Indication\" \/>\n<meta property=\"og:description\" content=\"Johnson &amp; Johnson (J&amp;J, NYSE: JNJ) announced that the European Commission (EC) has extended the marketing authorization for TREMFYA (guselkumab) as a subcutaneous treatment for moderate to severe plaque psoriasis in children and adolescents from age 6 years, making it the first IL\u201123 inhibitor approved for any pediatric indication.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=51821\" \/>\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=\"2025-12-23T04:53:45+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-12-23T04:53:46+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/12\/2305.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"606\" \/>\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. 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