FDA approves Gazyva, the first drug for a rare kidney disease that can lead to kidney failure
File photo: Roche — a vial of Gazyva (obinutuzumab)The U.S. Food and Drug Administration has approved Gazyva (obinutuzumab) for adults with primary membranous nephropathy, a rare kidney disease — the first drug ever approved specifically to treat the condition.
The approval, announced Friday, covers adults with the disease who are at risk of it getting worse, to bring protein in the urine back down — a state doctors call remission of proteinuria. Until now, no drug had been approved by the FDA or Europe's medicines agency for this form of kidney disease, and doctors treated it with drugs used off-label.
Primary membranous nephropathy is a rare disease in which the immune system attacks the glomeruli, the tiny filters in the kidneys that clean waste from the blood. The damaged filters leak large amounts of protein into the urine, and patients can develop high cholesterol, high blood pressure, severe swelling, fatigue, and kidney failure. When left untreated, up to 30% of patients progress to kidney failure over 10 years, according to Genentech, the Roche company that makes Gazyva.
The decision was based on the MAJESTY trial, a Phase 3 study of 142 adults with the disease, published in the New England Journal of Medicine. Patients were randomly assigned to receive either Gazyva or tacrolimus, an immune-suppressing drug sometimes used off-label for the condition, and followed for 104 weeks. At two years, 36% of patients on Gazyva had reached complete remission of protein in the urine, compared with 6% of those on tacrolimus, the FDA said. The journal's analysis, which used a different statistical method for missing data, put the figures at 37% versus 6%.
Gazyva was already approved for certain blood cancers, active lupus nephritis, and childhood-onset idiopathic nephrotic syndrome. The new approval came with Breakthrough Therapy, Orphan Drug, and Priority Review designations from the FDA.
The drug's label carries a boxed warning for reactivation of hepatitis B virus and for progressive multifocal leukoencephalopathy, a rare and serious brain infection that can occur in people with a weakened immune system. The most common side effects seen in the kidney-disease trial were infusion-related reactions and upper respiratory tract infections, the FDA said.
Sources: U.S. Food and Drug Administration, "FDA Approves First Drug to Treat Adults with Primary Membranous Nephropathy" (Nov. 13, 2026); HCPLive, "FDA approves Obinutuzumab (Gazyva) for Primary Membranous Nephropathy" (Nov. 13, 2026); Fervenza FC et al., "Obinutuzumab or Tacrolimus in Primary Membranous Nephropathy," New England Journal of Medicine (2026).
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