{"id":28855,"date":"2025-03-06T21:35:34","date_gmt":"2025-03-06T13:35:34","guid":{"rendered":"https:\/\/flcube.com\/?p=28855"},"modified":"2025-03-06T21:35:36","modified_gmt":"2025-03-06T13:35:36","slug":"roches-gazyva-receives-fda-review-acceptance-for-lupus-nephritis-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=28855","title":{"rendered":"Roche’s Gazyva Receives FDA Review Acceptance for Lupus Nephritis Treatment"},"content":{"rendered":"\n

Swiss pharmaceutical giant Roche (SWX: ROG<\/a>, OTCMKTS: RHHBY<\/a>) has announced that the US Food and Drug Administration ()FDA has accepted for review its supplemental Biologics License Application (sBLA) for Gazyva\/Gazyvaro (obinutuzumab) for the treatment of lupus nephritis. The FDA is expected to make its decision by October 2025. The filing is supported by positive results from the Phase III REGENCY study, which demonstrated improved complete renal response (CRR) with Gazyva\/Gazyvaro plus standard therapy compared with standard therapy alone.<\/p>\n\n\n\n

REGENCY Study Highlights<\/strong>
The Phase III REGENCY study provided robust evidence for the efficacy of Gazyva\/Gazyvaro in lupus nephritis. The trial showed a significant improvement in complete renal response when Gazyva\/Gazyvaro was added to standard therapy, compared to standard therapy alone. This groundbreaking data underscores the potential of Gazyva\/Gazyvaro to address a significant unmet need in the treatment of this devastating autoimmune disease.<\/p>\n\n\n\n

Mechanism of Action<\/strong>
Obinutuzumab is a Type II engineered humanized monoclonal antibody designed to attach to CD20, a protein found on certain types of B cells. In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys. By targeting B these cells, Gazyva\/Gazyvaro aims to reduce inflammation and improve renal outcomes in patients with lupus nephritis.<\/p>\n\n\n\n

Global Approval and Collaboration<\/strong>
Gazyva\/Gazyvaro is co-developed by Roche subsidiary Genentech and US-based Biogen Inc. (Nasdaq: BIIB) in the US. The drug is already approved in 100 countries for the treatment of multiple lymphoma types, highlighting its established safety and efficacy profile in oncology. This sBLA submission marks a significant step in expanding the therapeutic indications of Gazyva\/Gazyvaro beyond oncology into autoimmune diseases.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced that the US Food and…<\/p>\n","protected":false},"author":1,"featured_media":28856,"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":[65,38,940,163,939],"class_list":["post-28855","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-auto-immune","tag-market-approval-filings","tag-otcmkts-rhhby","tag-roche","tag-swx-rop"],"yoast_head":"\nRoche's Gazyva Receives FDA Review Acceptance for Lupus Nephritis Treatment - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced that the US Food and Drug Administration ()FDA has accepted for review its supplemental Biologics License Application (sBLA) for Gazyva\/Gazyvaro (obinutuzumab) for the treatment of lupus nephritis. The FDA is expected to make its decision by October 2025. 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