{"id":28593,"date":"2022-07-01T20:56:00","date_gmt":"2022-07-01T12:56:00","guid":{"rendered":"https:\/\/flcube.com\/?p=28593"},"modified":"2025-03-03T21:02:02","modified_gmt":"2025-03-03T13:02:02","slug":"takedas-obizur-prioritized-for-review-in-acquired-hemophilia-a-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=28593","title":{"rendered":"Takeda&#8217;s Obizur Prioritized for Review in Acquired Hemophilia A Treatment"},"content":{"rendered":"\n<p>The Center for Drug Evaluation (CDE) website indicates that Takeda Pharmaceutical Co., Ltd\u2019s Obizur (susoctocog alfa) has been prioritized for review for the on-demand treatment and control of bleeding events in adults with acquired hemophilia A.<\/p>\n\n\n\n<p><strong>Drug Profile and Mechanism<\/strong><br>Acquired hemophilia A is an acquired bleeding disorder characterized by reduced FVIII activity due to the presence of anticoagulant factor VIII autoantibodies in the blood. It is marked by spontaneous bleeding episodes in patients with no prior bleeding history or family history of bleeding, or abnormal bleeding during surgery, trauma, or invasive testing. The annual incidence is about 1.5 per 1 million people, with approximately 60.9% of patients experiencing severe bleeding at their first visit.<\/p>\n\n\n\n<p>Obizur, the first recombinant porcine FVIII (rpFVIII) product approved by the US FDA and European Medicine Agency (EMA) for acquired hemophilia A, has a structure and sequence similar to human coagulation factor VIII (FVIII) and is not easily inactivated by anti-human FVIII autoantibodies. It can replace human FVIII to achieve a significant hemostatic effect.<\/p>\n\n\n\n<p><strong>Clinical Study Results<\/strong><br>A prospective, multi-center, open Phase II \/ III study enrolled patients with acquired hemophilia A, with 945 receiving rpFVIII as first-line treatment. 100% of patients experienced a therapeutically evaluable response (cessation or reduction of bleeding) within 24 hours of dosing. Additionally, as a recombinant protein, Obizur reduces the risk of transmission of blood-borne pathogens.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Center for Drug Evaluation (CDE) website indicates that Takeda Pharmaceutical Co., Ltd\u2019s Obizur (susoctocog&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"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":[80,24,2410,345],"class_list":["post-28593","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-priority-reviews","tag-rare-orphan-disease-drugs","tag-special-review-status","tag-takeda"],"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>Takeda&#039;s Obizur Prioritized for Review in Acquired Hemophilia A Treatment - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The Center for Drug Evaluation (CDE) website indicates that Takeda Pharmaceutical Co., Ltd\u2019s Obizur (susoctocog alfa) has been prioritized for review for the on-demand treatment and control of bleeding events in adults with acquired hemophilia A.\" \/>\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=28593\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Takeda&#039;s Obizur Prioritized for Review in Acquired Hemophilia A Treatment\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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