{"id":29925,"date":"2025-03-19T15:05:09","date_gmt":"2025-03-19T07:05:09","guid":{"rendered":"https:\/\/flcube.com\/?p=29925"},"modified":"2025-03-19T15:05:12","modified_gmt":"2025-03-19T07:05:12","slug":"johnson-johnsons-nipocalimab-receives-fda-fast-track-designation-for-sjogrens-disease","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=29925","title":{"rendered":"Johnson & Johnson’s Nipocalimab Receives FDA Fast Track Designation for Sj\u00f6gren’s Disease"},"content":{"rendered":"\n

US giant Johnson & Johnson (J&J; NYSE: JNJ<\/a>) announced receiving Fast Track designation (FTD) from the US FDA for its nipocalimab as a treatment for adult patients with moderate-to-severe Sj\u00f6gren’s disease (SjD). This designation follows the monoclonal antibody’s Breakthrough Therapy Designation (BTD) received from the agency late last year.<\/p>\n\n\n\n

Mechanism of Action<\/strong>
Nipocalimab is a human immunoglobulin G (IgG)1 monoclonal antibody that binds to the neonatal Fc receptor (FcRn) with high specificity and affinity. This mechanism enables the drug to reduce IgG levels in the bloodstream, including pathogenic autoantibodies, by over 75% in some studies.<\/p>\n\n\n\n

Significance for Sj\u00f6gren’s Disease Treatment<\/strong>
Sj\u00f6gren’s disease is a chronic autoimmune disorder characterized by the infiltration of lymphocytes into exocrine glands, leading to symptoms such as dry eyes and mouth. The condition affects approximately 1 in 1,000 people, with women being nine times more likely to develop the disease than men. Current treatment options are limited, making nipocalimab’s development a significant step forward in addressing this unmet medical need.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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

US giant Johnson & Johnson (J&J; NYSE: JNJ) announced receiving Fast Track designation (FTD) from…<\/p>\n","protected":false},"author":1,"featured_media":29933,"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":[150,149,858,24],"class_list":["post-29925","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-jj","tag-johnson-johnson","tag-nyse-jnj","tag-rare-orphan-disease-drugs"],"yoast_head":"\nJohnson & Johnson's Nipocalimab Receives FDA Fast Track Designation for Sj\u00f6gren's Disease - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"US giant Johnson & Johnson (J&J; NYSE: JNJ) announced receiving Fast Track designation (FTD) from the US FDA for its nipocalimab as a treatment for adult patients with moderate-to-severe Sj\u00f6gren's disease (SjD). This designation follows the monoclonal antibody's Breakthrough Therapy Designation (BTD) received from the agency late last year.\" \/>\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=29925\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Johnson & Johnson's Nipocalimab Receives FDA Fast Track Designation for Sj\u00f6gren's Disease\" \/>\n<meta property=\"og: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 property=\"og:url\" content=\"https:\/\/flcube.com\/?p=29925\" \/>\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=\"2025-03-19T07:05:09+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-03-19T07:05:12+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/03\/1905-png.avif\" \/>\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: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=29925#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=29925\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Johnson & Johnson’s Nipocalimab Receives FDA Fast Track Designation for Sj\u00f6gren’s Disease\",\"datePublished\":\"2025-03-19T07:05:09+00:00\",\"dateModified\":\"2025-03-19T07:05:12+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=29925\"},\"wordCount\":190,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=29925#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/03\\\/1905-png.avif\",\"keywords\":[\"J&J\",\"Johnson & Johnson\",\"NYSE: JNJ\",\"Rare \\\/ orphan disease drugs\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=29925#respond\"]}],\"copyrightYear\":\"2025\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=29925\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=29925\",\"name\":\"Johnson & Johnson's Nipocalimab Receives FDA Fast Track Designation for Sj\u00f6gren's Disease - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=29925#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=29925#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/03\\\/1905-png.avif\",\"datePublished\":\"2025-03-19T07:05:09+00:00\",\"dateModified\":\"2025-03-19T07:05:12+00:00\",\"description\":\"US giant Johnson & Johnson (J&J; NYSE: JNJ) announced receiving Fast Track designation (FTD) from the US FDA for its nipocalimab as a treatment for adult patients with moderate-to-severe Sj\u00f6gren's disease (SjD). This designation follows the monoclonal antibody's Breakthrough Therapy Designation (BTD) received from the agency late last year.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=29925#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=29925\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=29925#primaryimage\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/03\\\/1905-png.avif\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2025\\\/03\\\/1905-png.avif\",\"width\":1080,\"height\":608,\"caption\":\"Johnson & Johnson's Nipocalimab Receives FDA Fast Track Designation for Sj\u00f6gren's Disease\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=29925#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Johnson & Johnson’s Nipocalimab Receives FDA Fast Track Designation for Sj\u00f6gren’s Disease\"}]},{\"@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":"Johnson & Johnson's Nipocalimab Receives FDA Fast Track Designation for Sj\u00f6gren's Disease - Insight, China's Pharmaceutical Industry","description":"US giant Johnson & Johnson (J&J; NYSE: JNJ) announced receiving Fast Track designation (FTD) from the US FDA for its nipocalimab as a treatment for adult patients with moderate-to-severe Sj\u00f6gren's disease (SjD). This designation follows the monoclonal antibody's Breakthrough Therapy Designation (BTD) received from the agency late last year.","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=29925","og_locale":"en_US","og_type":"article","og_title":"Johnson & Johnson's Nipocalimab Receives FDA Fast Track Designation for Sj\u00f6gren's Disease","og_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","og_url":"https:\/\/flcube.com\/?p=29925","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2025-03-19T07:05:09+00:00","article_modified_time":"2025-03-19T07:05:12+00:00","og_image":[{"width":1080,"height":608,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/03\/1905-png.avif","type":"image\/png"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=29925#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=29925"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Johnson & Johnson’s Nipocalimab Receives FDA Fast Track Designation for Sj\u00f6gren’s Disease","datePublished":"2025-03-19T07:05:09+00:00","dateModified":"2025-03-19T07:05:12+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=29925"},"wordCount":190,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"image":{"@id":"https:\/\/flcube.com\/?p=29925#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/03\/1905-png.avif","keywords":["J&J","Johnson & Johnson","NYSE: JNJ","Rare \/ orphan disease drugs"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=29925#respond"]}],"copyrightYear":"2025","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=29925","url":"https:\/\/flcube.com\/?p=29925","name":"Johnson & Johnson's Nipocalimab Receives FDA Fast Track Designation for Sj\u00f6gren's Disease - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/flcube.com\/?p=29925#primaryimage"},"image":{"@id":"https:\/\/flcube.com\/?p=29925#primaryimage"},"thumbnailUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/03\/1905-png.avif","datePublished":"2025-03-19T07:05:09+00:00","dateModified":"2025-03-19T07:05:12+00:00","description":"US giant Johnson & Johnson (J&J; NYSE: JNJ) announced receiving Fast Track designation (FTD) from the US FDA for its nipocalimab as a treatment for adult patients with moderate-to-severe Sj\u00f6gren's disease (SjD). This designation follows the monoclonal antibody's Breakthrough Therapy Designation (BTD) received from the agency late last year.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=29925#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=29925"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/?p=29925#primaryimage","url":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/03\/1905-png.avif","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2025\/03\/1905-png.avif","width":1080,"height":608,"caption":"Johnson & Johnson's Nipocalimab Receives FDA Fast Track Designation for Sj\u00f6gren's Disease"},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=29925#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Johnson & Johnson’s Nipocalimab Receives FDA Fast Track Designation for Sj\u00f6gren’s Disease"}]},{"@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\/03\/1905-png.avif","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/29925","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=29925"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/29925\/revisions"}],"predecessor-version":[{"id":29934,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/29925\/revisions\/29934"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/media\/29933"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=29925"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=29925"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=29925"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}