FDA Gives Priority Review to Roche’s Kidney Disease Therapy

Roche has announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to its supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) as a treatment for primary membranous nephropathy (pMN), a rare autoimmune kidney disease.

The Priority Review shortens the FDA’s review timeline for medicines that could offer significant improvements in treating serious diseases. The agency is expected to make its approval decision by November 2026.

The latest regulatory milestone is based on positive results from the Phase 3 MAJESTY clinical trial, which showed that Gazyva/Gazyvaro performed better than the commonly used immunosuppressive medicine tacrolimus in adults with primary membranous nephropathy.

Earlier this year, the FDA also granted Breakthrough Therapy Designation to Gazyva/Gazyvaro for pMN, highlighting the medicine’s potential to address an important unmet medical need. This is the second kidney disease indication to receive Priority Review for Gazyva/Gazyvaro in recent months, following its review for idiopathic nephrotic syndrome in May 2026.

Primary membranous nephropathy is a chronic autoimmune disease in which the body’s immune system mistakenly attacks the kidneys. The condition damages the tiny filtering units inside the kidneys, leading to protein leakage into the urine, swelling, and a gradual decline in kidney function. Without effective treatment, many patients may eventually develop kidney failure and require dialysis or a kidney transplant.

Currently, there are no FDA-approved treatments specifically for primary membranous nephropathy, making the development of new treatment options an important priority for both patients and healthcare providers.

Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development, said the FDA’s Priority Review represents an important step forward for people living with the disease.

He explained that Gazyva/Gazyvaro works by targeting tissue-resident B cells, a type of immune cell believed to play a key role in causing primary membranous nephropathy. By addressing one of the underlying causes of the disease, the medicine has the potential to help more patients achieve complete remission and preserve kidney function.

The Phase 3 MAJESTY study met its primary goal, with 36.9% of patients treated with Gazyva/Gazyvaro achieving complete remission after two years, compared with 5.7% of patients receiving tacrolimus. Complete remission is considered the most important treatment goal because it can significantly reduce the risk of long-term kidney damage and kidney failure.

The study also showed that Gazyva/Gazyvaro was superior to tacrolimus in several secondary measures, including overall remission, which includes both complete and partial remission, as well as complete remission after 76 weeks of treatment.

Researchers reported that the medicine’s safety profile was consistent with previous studies, and no new safety concerns were identified during the trial.

The MAJESTY trial results were presented as a late-breaking study at the 63rd European Renal Association (ERA) Congress in June 2026 and were also published in the New England Journal of Medicine, providing additional scientific support for the therapy.

Roche said it is also submitting the MAJESTY data to regulatory authorities in other regions, including the European Medicines Agency (EMA).

The company continues to expand the use of Gazyva/Gazyvaro in immune-mediated diseases. The medicine has already shown positive Phase 3 results in lupus nephritis, systemic lupus erythematosus (SLE), and idiopathic nephrotic syndrome. It is currently approved in both the United States and the European Union for adults with active lupus nephritis receiving standard treatment.

Beyond Gazyva/Gazyvaro, Roche is continuing to develop new therapies for immune-related diseases. Its research pipeline includes Lunsumio (mosunetuzumab), an investigational bispecific antibody currently being studied as a potential treatment for systemic lupus erythematosus.

If approved by the FDA later this year, Gazyva/Gazyvaro could become the first FDA-approved treatment specifically for primary membranous nephropathy, offering a new option for patients living with a disease that currently has limited treatment choices and a high risk of long-term kidney damage.