{"id":35972,"date":"2025-06-25T12:38:32","date_gmt":"2025-06-25T04:38:32","guid":{"rendered":"https:\/\/flcube.com\/?p=35972"},"modified":"2025-06-25T12:38:33","modified_gmt":"2025-06-25T04:38:33","slug":"gsk-gains-fda-clearance-for-benlysta-autoinjector-in-pediatric-lupus-nephritis","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=35972","title":{"rendered":"GSK Gains FDA Clearance for Benlysta Autoinjector in Pediatric Lupus Nephritis"},"content":{"rendered":"\n

UK-based GlaxoSmithKline (GSK; NYSE: GSK<\/a>) announced that it has received clearance from the US Food and Drug Administration (FDA) to market its 200 mg\/mL autoinjector of Benlysta (belimumab). The approval is for subcutaneous injection in patients aged five years and older with active lupus nephritis (LN) who are receiving standard therapy.<\/p>\n\n\n\n

Drug Mechanism<\/strong>
Benlysta is a B-lymphocyte stimulator (BlyS)-specific inhibiting monoclonal antibody (mAb). It binds to soluble BLyS to suppress the survival of B cells, including autoreactive B cells, and reduce their differentiation into immunoglobulin-producing plasma cells.<\/p>\n\n\n\n

Approval Significance<\/strong>
Initially approved by the FDA for treating active systemic lupus erythematosus (SLE), Benlysta remains the only biologic approved for both SLE and LN\u2014including pediatric populations\u2014in over 50 years. This latest approval introduces a subcutaneous injection option for pediatric LN patients, enabling at-home treatment.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

UK-based GlaxoSmithKline (GSK; NYSE: GSK) announced that it has received clearance from the US Food…<\/p>\n","protected":false},"author":1,"featured_media":35973,"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":[65,278,184,914,15],"class_list":["post-35972","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-auto-immune","tag-glaxosmithkline","tag-gsk","tag-nyse-gsk","tag-product-approvals"],"yoast_head":"\nGSK Gains FDA Clearance for Benlysta Autoinjector in Pediatric Lupus Nephritis - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"UK-based GlaxoSmithKline (GSK; NYSE: GSK) announced that it has received clearance from the US Food and Drug Administration (FDA) to market its 200 mg\/mL autoinjector of Benlysta (belimumab). 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