{"id":36123,"date":"2025-06-26T22:53:00","date_gmt":"2025-06-26T14:53:00","guid":{"rendered":"https:\/\/flcube.com\/?p=36123"},"modified":"2025-06-26T22:53:01","modified_gmt":"2025-06-26T14:53:01","slug":"sanofis-riliprubart-granted-orphan-drug-status-for-antibody-mediated-rejection-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=36123","title":{"rendered":"Sanofi&#8217;s Riliprubart Granted Orphan Drug Status for Antibody-Mediated Rejection Treatment"},"content":{"rendered":"\n<p>France-based major Sanofi (<a href=\"https:\/\/www.google.com\/finance\/quote\/SNY:NASDAQ\">NASDAQ: SNY<\/a>) has secured Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for riliprubart, an investigational treatment for antibody-mediated rejection (AMR) in organ transplant recipients. This marks a significant step forward in addressing a condition with limited therapeutic options.<\/p>\n\n\n\n<p><strong>Drug Profile<\/strong><br>Riliprubart is a potential first-in-class humanized IgG4 monoclonal antibody designed to selectively inhibit activated C1s in the classical complement pathway of the innate immune system. This mechanism of action positions it to address the underlying pathology of AMR, a condition that can lead to transplant organ dysfunction and failure.<\/p>\n\n\n\n<p><strong>Clinical Development<\/strong><br>Previously, riliprubart received Orphan Drug Designations from both the FDA and European Commission for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). Building on this momentum, Sanofi is currently conducting a Phase II study to evaluate the safety and efficacy of riliprubart in preventing and treating active AMR in kidney transplant recipients.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>France-based major Sanofi (NASDAQ: SNY) has secured Orphan Drug Designation (ODD) from the US Food&#8230;<\/p>\n","protected":false},"author":1,"featured_media":36124,"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":[867,24,147],"class_list":["post-36123","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-nasdaq-sny","tag-rare-orphan-disease-drugs","tag-sanofi"],"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>Sanofi&#039;s Riliprubart Granted Orphan Drug Status for Antibody-Mediated Rejection Treatment - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"France-based major Sanofi (NASDAQ: SNY) has secured Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for riliprubart, an investigational treatment for antibody-mediated rejection (AMR) in organ transplant recipients. 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This marks a significant step forward in addressing a condition with limited therapeutic options.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=36123\" \/>\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=\"2025-06-26T14:53:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-06-26T14:53:01+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/06\/2604-1.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. 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