{"id":5979,"date":"2019-09-20T11:57:33","date_gmt":"2019-09-20T06:27:33","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=5979"},"modified":"2025-05-08T11:49:57","modified_gmt":"2025-05-08T06:19:57","slug":"gazyva-for-lupus-nephritis","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/gazyva-for-lupus-nephritis","title":{"rendered":"Roche\u2019s Gazyva receives FDA Breakthrough designation for Lupus nephritis\ufeff"},"content":{"rendered":"\n

The US FDA has in a recent move granted Roche\u2019s\nGazyva Breakthrough Therapy Designation (BTD) for adults with lupus nephritis.<\/p>\n\n\n\n

Gazyva<\/strong> (obinutuzumab) is an anti-cancer (“antineoplastic” or “cytotoxic”) chemotherapy drug. Classified as a “monoclonal antibody”, Gazyva is a CD20-directed cytolytic antibody. The drug is recommended in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL). Furthermore, Gazyva is also indicated in combination with bendamustine for the treatment of of follicular lymphoma (FL) with a prior rituximab-containing therapy regimen.<\/p>\n\n\n\n

The decision for granting a Breakthrough designation to Gazyva came on the basis of results of the phase II NOBILITY trial in adult patients with proliferative lupus nephritis.<\/p>\n\n\n\n

The administration of Gazyva in combination with\nmycophenolate mofetil or mycophenolic acid and corticosteroids validated its\nefficacy in patients with lupus nephritis.<\/p>\n\n\n\n

Lupus nephritis<\/strong><\/p>\n\n\n\n

Lupus nephritis is an autoimmune kidney disease caused by systemic lupus erythematosus.<\/p>\n\n\n\n

Symptoms of lupus nephritis include foamy urine and edema.
The person may also develop high blood pressure. <\/p>\n\n\n\n

Lupus nephritis<\/strong> Epidemiology<\/strong><\/p>\n\n\n\n

Lupus nephritis is clinically evident in 50-60% of\npatients with systemic lupus erythematosus (SLE), and it is histologically\nevident in most SLE patients, even those without clinical manifestations of\nrenal disease.<\/p>\n\n\n\n

Kidney damage is one of the common health problems associated with lupus. In adults, as many as 5 out of 10 lupus patients<\/a> will have kidney disease. In children, the number is 8 out of 10.<\/p>\n\n\n\n

Lupus nephritis<\/strong> Therapeutic\nlandscape<\/strong><\/p>\n\n\n\n

The treatment of LN consists of two phases –\ninduction and maintenance. Induction therapy refers to the initial therapeutic\nregimen given in an attempt to produce remission of active disease.<\/p>\n\n\n\n

The combination of cyclophosphamide and corticosteroids (methylprednisolone) administered as induction therapy has proved to be effective in randomized controlled trials. Moreover, the studies revealed that the combination is more effective than corticosteroids alone.<\/p>\n\n\n\n

Mycophenolate mofetil (MMF) was introduced as a therapeutic option for LN in the beginning of the 21st century.<\/p>\n\n\n\n

Various therapies have been studied for maintenance\ntherapy, including azathioprine, MMF, and cyclophosphamide, all combined with\ncorticosteroids.<\/p>\n\n\n\n

Lupus nephritis<\/strong> Upcoming\ntherapies<\/strong><\/p>\n\n\n\n

Many other agents are currently under investigations\nto study how they impact Lupus nephritis treatment including rituximab,\nbelimumab, and tacrolimus.<\/p>\n\n\n\n

The Lupus Nephritis market is expected to experience positive growth in the coming years owing to the launch of distinctive emerging therapies in the coming years.<\/p>\n\n\n\n

Companies like Aurinia Pharmaceuticals (Voclosporin), Roche (Obinutuzumab), AstraZeneca (Anifrolumab), Novartis (CFZ533), Boehringer Ingelheim (BI 655064) and many other pharma companies are working towards the expansion of Lupus Nephritis treatment therapies.<\/a><\/p>\n\n\n\n

Voclosporin, an investigational drug, is a novel and\npotentially best-in-class CNI with clinical data in over 2,400 patients across\nindications. Voclosporin is an immunosuppressant, with a synergistic and dual\nmechanism of action.<\/p>\n\n\n\n

Apart from the late-stage therapies, there are other Lupus nephritis promising candidates<\/a> <\/a>as well, which are still in the early stage of development.<\/p>\n\n\n\n

Kezar Lifesciences\u2019 KZR-616 is one of the early-stage molecules, which is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across autoimmune diseases. The drug is currently being tested under Phase-1\/2 clinical trial. <\/p>\n\n\n\n

Lupus nephritis<\/strong> Market trends<\/strong><\/p>\n\n\n\n

The dynamics of Lupus Nephritis market<\/a><\/strong> is anticipated to change in the coming years owing to the improvement in the diagnosis methodologies, rising awareness of the disease, incremental healthcare spending across the world and expected launch of emerging therapies during the forecast period of 2018-2028.<\/p>\n","protected":false},"excerpt":{"rendered":"

The US FDA has in a recent move granted Roche\u2019s Gazyva Breakthrough Therapy Designation (BTD) for adults with lupus nephritis. Gazyva (obinutuzumab) is an anti-cancer (“antineoplastic” or “cytotoxic”) chemotherapy drug. Classified as a “monoclonal antibody”, Gazyva is a CD20-directed cytolytic antibody. The drug is recommended in combination with chlorambucil, for the treatment of patients with […]<\/p>\n","protected":false},"author":1,"featured_media":5981,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[17],"tags":[704,6248,6250,17782,6249,524],"industry":[17225],"therapeutic_areas":[17227],"class_list":["post-5979","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","tag-fda","tag-lupus-nephritis","tag-lupus-nephritis-market","tag-lupus-nephritis-pipeline","tag-lupus-nephritis-therapy","tag-roche","industry-pharmaceutical","therapeutic_areas-immunological-and-autoimmune-disorders"],"acf":[],"yoast_head":"\nRoche's Gazyva earns Breakthrough designation for Lupus nephritis\ufeff<\/title>\n<meta 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href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Articles<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Articles<\/span>"]},"tags":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">FDA<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Lupus nephritis<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Lupus nephritis market<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Lupus Nephritis Pipeline<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Lupus nephritis therapy<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Roche<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">FDA<\/span>","<span class=\"advgb-post-tax-term\">Lupus 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