FDA Approves Gazyva as First Membranous Nephropathy Drug

A rare kidney disease has its first drug. The Food and Drug Administration approved Gazyva (obinutuzumab) injection on November 13, 2026, to treat adults with primary membranous nephropathy who are at risk of disease progression, with the goal of inducing remission of proteinuria, the protein leaking into urine that marks the disease. The agency was plain about the milestone: it's the first drug approved specifically for adults with this condition.

Primary membranous nephropathy starts with the immune system attacking the glomeruli, the tiny filters that clean waste from the blood. The filters inflame and scar, and they begin leaking large amounts of protein. Patients can develop high cholesterol, high blood pressure, severe swelling and fatigue, and the damage can end in kidney failure. Until this approval, doctors treated it with drugs approved for other diseases or used off-label, which is why a label written for this disease alone changes the footing of every prescription.

The evidence comes from MAJESTY (NCT04629248), a Phase 3, randomized, controlled, open-label, multicenter study in 142 adults. Over a main study period of 104 weeks, patients received either Gazyva or tacrolimus, a drug sometimes used off-label for the disease. The primary endpoint was strict: complete remission of proteinuria, defined as a urine protein-creatinine ratio of no more than 0.3 grams per gram with a stable estimated glomerular filtration rate, and no rescue therapy, treatment failure or early exit from the study.

Gazyva cleared that bar six times as often. At week 104, 36 percent of the Gazyva group had achieved complete remission, compared with 6 percent of the tacrolimus group. The trial's results were published in The New England Journal of Medicine in 2026. The gap matters because remission of proteinuria is the outcome tied to keeping kidney function: every patient who reaches it is a patient whose filters have stopped leaking at a damaging rate.

The approval adds a fourth chapter to a drug that keeps moving into immune disease. Gazyva was already approved for certain cancers, for active lupus nephritis and for childhood-onset idiopathic nephrotic syndrome. Its label carries boxed warnings for hepatitis B virus reactivation and for progressive multifocal leukoencephalopathy, a rare and serious brain infection seen in people with weakened immune systems. In the kidney study, the most common side effects were infusion-related reactions and upper respiratory tract infections.

Regulators signaled the priority early. Gazyva held Breakthrough Therapy, Orphan Drug and Priority Review designations for this use, three separate markers that the agency saw an unmet need and a drug that might fill it. For patients, the practical questions now move to clinics: who starts, who switches from an off-label regimen, and how payers price a first-in-disease approval. Those answers come next. The label itself is settled.