{"id":13958,"date":"2024-11-21T14:52:59","date_gmt":"2024-11-21T06:52:59","guid":{"rendered":"https:\/\/flcube.com\/?p=13958"},"modified":"2024-11-21T14:53:02","modified_gmt":"2024-11-21T06:53:02","slug":"ucbs-bimzelx-receives-us-fda-approval-for-moderate-to-severe-hidradenitis-suppurativa","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=13958","title":{"rendered":"UCB’s Bimzelx Receives US FDA Approval for Moderate to Severe Hidradenitis Suppurativa"},"content":{"rendered":"\n

Belgium-based biopharmaceutical company UCB (FRA: UNC<\/a>) has announced that the US Food and Drug Administration (FDA) has granted another indication approval for its drug Bimzelx (bimekizumab), an interleukin 17A (IL-17A) and IL-17F targeted antibody. The FDA has approved Bimzelx for the treatment of adults with moderate to severe hidradenitis suppurativa (HS).<\/p>\n\n\n\n

Bimzelx’s Expanding Indication Portfolio<\/strong>
Bimzelx, the world’s fourth IL-17-targeted drug, was initially approved in the US in October 2023 for the treatment of moderate to severe plaque psoriasis in adults. Since then, it has earned approval in three additional indications: adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS). Internationally, Bimzelx is also registered in China, where it received approval in July this year to treat adult patients with active AS who have responded inadequately or are intolerant to conventional therapy.<\/p>\n\n\n\n

Phase 3 Study Results Supporting Latest Approval<\/strong>
The latest approval for HS treatment is supported by the results from the BE HEARD I and BE HEARD II Phase 3 studies. These studies demonstrated that a higher proportion of patients treated with bimekizumab-bkzx experienced a 50 percent or greater improvement in HS signs and symptoms at Week 16, as measured by the primary endpoint HiSCR50.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

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

Belgium-based biopharmaceutical company UCB (FRA: UNC) has announced that the US Food and Drug Administration…<\/p>\n","protected":false},"author":1,"featured_media":13959,"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":[65,1158,15,131],"class_list":["post-13958","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-auto-immune","tag-fra-unc","tag-product-approvals","tag-ucb"],"yoast_head":"\nUCB's Bimzelx Receives US FDA Approval for Moderate to Severe Hidradenitis Suppurativa - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Belgium-based biopharmaceutical company UCB has announced that the US Food and Drug Administration (FDA) has granted another indication approval for its drug Bimzelx (bimekizumab), an interleukin 17A (IL-17A) and IL-17F targeted antibody. 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