The U.S. Food and Drug Administration (FDA) has approved Gazyva/Gazyvaro (obinutuzumab) for the treatment of adults with active lupus nephritis who are receiving standard of care. In addition, the approval includes a shorter 90-minute infusion time after the first infusion for eligible patients.
Lupus nephritis is a kidney disorder that is a complication of systemic lupus erythematosus, commonly known as lupus. It is characterized by an irreversible loss of nephrons that lead to progressive loss of kidney function. The symptoms of lupus nephritis include blood in the urine, a foamy appearance to the urine, high blood pressure, and swelling in any part of the body. The condition more commonly affects women, mostly of color and usually of childbearing age.
Obinutuzumab is a type 2 engineered humanized monoclonal antibody designed to attach to the CD20 protein found on certain B cells, reducing inflammation that damages the kidneys and reduces their ability to function properly. Following four initial doses in the first year of treatment, obinuzutumab is then administered twice yearly.
The FDA approval follows positive results from the REGENCY study. The REGENCY clinical trial (NCT04221477) is a phase 3, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of obinuzutumab plus standard of care in patients with active/chronic lupus nephritis. The study enrolled a total of 271 patients.
Complete renal response was achieved in 46.4% of patients treated with obinuzutumab compared to 33.1% on standard of care alone. Clinically meaningful improvements in complement levels and reductions in anti-dsDNA, corticosteroid use, and proteinuria were also observed, signalling improved disease control. The safety profile was consistent with the profile known for obinuzutumab in its hematology/oncology indications.
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To learn more about lupus nephritis and other rare kidney conditions, visit https://checkrare.com/diseases/kidney-and-urinary-diseases/
