Lupus Nephritis Pipeline
Oct 21, 2025
FDA Approves Genentech’s GAZYVA for Lupus Nephritis; Glaukos’ EPIOXA Wins FDA Approval for Keratoconus Treatment; FDA Accepts Replimune’s RP1 BLA Resubmission for Advanced Melanoma; Cogent’s Bezuclastinib Earns FDA Breakthrough Therapy for SM-AHN; Amgen’s TEZSPIRE Gets FDA Nod for Chronic Rhinosinusitis with Nasal Polyps
FDA Approves Genentech’s GAZYVA for Lupus Nephritis Genentech, a member of the Roche Group, announced that the FDA has approved GAZYVA (obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) receiving standard therapy. The approval is supported by data from the Phase II NOBILITY and P...
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May 05, 2025
Emerging Lupus Nephritis Therapies: Addressing Unmet Needs through Innovation and Mechanistic Targeting
Lupus nephritis is a serious and common complication of systemic lupus erythematosus (SLE), characterized by inflammation of the kidneys that can lead to progressive organ damage and increased mortality. Approximately one-third of adults with SLE present with lupus nephritis at diagnosis, and up to half will develo...
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Jan 27, 2023
Lupus Nephritis: A SILENT but SEVERE Systemic Lupus Erythematosus Manifestation
Lupus Nephritis (LN) is the most feared and common complication of systemic lupus erythematosus (SLE) and is responsible for the major share of morbidity and mortality of this disease. It affects around half of the systemic lupus erythematosus patients, and in ~35% of patients, lupus nephritis is the presenting fea...
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Sep 20, 2019
Roche’s Gazyva receives FDA Breakthrough designation for Lupus nephritis
The US FDA has in a recent move granted Roche’s 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...
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