{"id":14869,"date":"2024-11-25T16:20:11","date_gmt":"2024-11-25T08:20:11","guid":{"rendered":"https:\/\/flcube.com\/?p=14869"},"modified":"2024-11-25T16:20:13","modified_gmt":"2024-11-25T08:20:13","slug":"jj-submits-sbla-to-fda-for-subcutaneous-tremfya-regimen-in-ulcerative-colitis","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=14869","title":{"rendered":"J&J Submits sBLA to FDA for Subcutaneous Tremfya Regimen in Ulcerative Colitis"},"content":{"rendered":"\n

Johnson & Johnson (J&J; NYSE: JNJ<\/a>) has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for a subcutaneous (SC) induction regimen of Tremfya (guselkumab). The application is based on results from the Phase III ASTRO study and seeks approval for the drug to treat adults with moderately to severely active ulcerative colitis (UC).<\/p>\n\n\n\n

Phase III ASTRO Study Success and Primary Endpoint Achievement<\/strong>
The Phase III ASTRO study successfully met its primary endpoint, demonstrating statistically significant and clinically meaningful results for clinical remission at Week 12 with a 400 mg SC induction dose of Tremfya. The drug was administered at Weeks 0, 4, and 8, marking a significant advancement in treatment options for UC patients. All secondary endpoints, including endoscopic improvement and histologic-endoscopic mucosal improvement (HEMI), were also successfully achieved.<\/p>\n\n\n\n

Tremfya: The First Dual-Acting Monoclonal Antibody for UC<\/strong>
Tremfya, the world\u2019s first and only approved dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, was previously approved in the US in September this year for use in moderately to severely active UC. This approval was for an intravenous induction regimen, and the new sBLA seeks to expand the administration options to include a subcutaneous induction regimen, offering more flexibility for patients.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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

Johnson & Johnson (J&J; NYSE: JNJ) has submitted a supplemental Biologics License Application (sBLA) to…<\/p>\n","protected":false},"author":1,"featured_media":14870,"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":[65,150,149,38,858],"class_list":["post-14869","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-auto-immune","tag-jj","tag-johnson-johnson","tag-market-approval-filings","tag-nyse-jnj"],"yoast_head":"\nJ&J Submits sBLA to FDA for Subcutaneous Tremfya Regimen in Ulcerative Colitis - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Johnson & Johnson (J&J; NYSE: JNJ) has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for a subcutaneous (SC) induction regimen of Tremfya (guselkumab). 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