FDA Approves Gazyva, First Drug for Primary Membranous Nephropathy, With 36% vs 6% Complete Remission in Phase 3 Trial
The U.S. Food and Drug Administration (FDA) on November 13, 2026 approved Gazyva (obinutuzumab) injection to treat adults with primary membranous nephropathy at risk of disease progression, to induce remission of proteinuria. It is the first drug approved specifically for the treatment of adults with primary membranous nephropathy. Gazyva was previously approved for treating certain cancers, active lupus nephritis, and childhood-onset idiopathic nephrotic syndrome.
Primary membranous nephropathy is a rare kidney disease caused by immune system attack on the glomeruli, the tiny filters in the kidneys that clean waste products from the blood. The glomeruli become inflamed and damaged, leaking large amounts of protein into the urine. Patients can develop high cholesterol, high blood pressure, severe swelling, fatigue, kidney failure, and other complications.
Efficacy and safety were evaluated in MAJESTY, a Phase 3, randomized, controlled, open-label, multicenter study in 142 adults with primary membranous nephropathy. During the main study period of 104 weeks, patients were randomly assigned to receive either Gazyva or tacrolimus, another treatment sometimes used off-label for the disease. The primary endpoint was the proportion of patients who achieved complete remission of proteinuria at week 104, defined as a urine protein-creatinine ratio of no more than 0.3 g/g with a stable estimated glomerular filtration rate, without receipt of rescue therapy, treatment failure, or early study discontinuation. The proportion achieving complete remission was 36% in the Gazyva group compared with 6% in the tacrolimus group, a significant difference.
Gazyva's label carries a boxed warning for hepatitis B virus reactivation and progressive multifocal leukoencephalopathy (PML), a rare and serious brain infection caused by a virus in people with a weakened immune system. The most common side effects in the study were infusion-related reactions and upper respiratory tract infection. See the full prescribing information for complete safety details.
The approval received Breakthrough Therapy, Orphan Drug, and Priority Review designations. (Source: U.S. Food and Drug Administration)
Source: U.S. Food and Drug Administration
Published by GSM · USA (original Chinese edition)
Photo: 图：美国食品药品监管局（FDA）总部大楼（固定图库联邦核心包）。 / Photo: Headquarters of the U.S. Food and Drug Administration (fixed federal-core asset-pack image).
