People living with lupus nephritis (LN), a serious kidney complication of lupus, now have a new treatment option. The U.S. Food and Drug Administration (FDA) has approved obinutuzumab (brand name Gazyva) for adults with active lupus nephritis who are already receiving standard therapy.

This approval offers new hope for patients managing the pain, fatigue, and uncertainty that come with lupus-related kidney inflammation. The therapy is designed to improve kidney outcomes, reduce disease flares, and potentially prevent kidney failure over time*

What Is Lupus Nephritis?

Lupus nephritis occurs when lupus, an autoimmune disease, causes the immune system to attack the kidneys. This inflammation damages the kidney’s filtering units, making it harder for the body to remove waste and control fluid balance.

People with lupus nephritis may experience:

• Swelling in the legs, feet, or around the eyes
• Foamy urine (a sign of protein leakage)
• High blood pressure
• Fatigue and joint pain

Left untreated, lupus nephritis can progress to kidney failure (end-stage kidney disease), which is why new treatment options are so important.

About Obinutuzumab (Gazyva)

Obinutuzumab is a monoclonal antibody, a type of targeted therapy that binds to a protein called CD20, found on certain immune cells known as B cells. By reducing the activity of these overactive B cells, the medication helps control the inflammation that damages kidney tissue in lupus nephritis.

It’s given as an IV infusion, with a shorter 90-minute infusion time available for eligible patients after the first dose.

• Patients receive four initial doses in the first year, followed by twice-yearly maintenance infusions.
• The treatment is used alongside standard lupus nephritis therapy, not as a replacement.

According to Genentech, the company behind Gazyva, this schedule makes treatment both effective and more convenient for many patients.

What the Research Shows

The FDA’s approval is based on two major clinical trials: NOBILITY (phase 2) and REGENCY (phase 3).

In the REGENCY trial, which included 271 patients in 15 countries:

• 46.4% of patients receiving obinutuzumab plus standard therapy achieved a complete renal response, compared with 33.1% on standard therapy alone.
• Participants also showed improvements in complement levels (markers of inflammation) and reductions in proteinuria, a key sign of kidney stress.
• Many were able to lower their corticosteroid doses, reducing potential long-term side effects.
• The drug’s safety profile was consistent with what’s already known from its use in cancer treatment.

Dr. Levi Garraway, Genentech’s Chief Medical Officer, explained:

“People with lupus nephritis who achieve a complete renal response are more likely to preserve kidney function and delay—or even prevent—the progression to end-stage kidney disease.”

Why This Matters

Until recently, treatment options for lupus nephritis were limited. While immunosuppressive drugs and steroids can help, many patients still face worsening kidney function.

This approval marks a major step forward:

• It offers a targeted therapy with evidence-backed kidney benefits.
• It provides a shorter infusion time and less frequent dosing.
• It could help more patients achieve lasting disease control and maintain kidney function.

Louise Vetter, CEO of the Lupus Foundation of America, called the approval “renewed hope for people with lupus nephritis and their loved ones.”

The Road Ahead

Obinutuzumab is also being studied for:

• Systemic lupus erythematosus (SLE)
• Membranous nephropathy
• Idiopathic nephrotic syndrome
• Pediatric lupus nephritis

These studies may help expand its use and provide additional treatment options for people with other immune-related kidney conditions.

What This Means for Patients

If you or someone you love has lupus nephritis, here are some key takeaways:

• Talk to your doctor: Ask if obinutuzumab could be appropriate based on your health, treatment history, and insurance coverage.
• Expect ongoing monitoring: Even with new treatments, regular lab work and kidney function tests are essential.
• Stay informed: Clinical trials continue to improve our understanding of how targeted therapies can protect kidney function.

* HCP Live (October 20, 2025). “FDA Approves Obinutuzumab (Gazyva) for Lupus Nephritis.” hcplive.com

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