Genentech, part of the Roche Group, has announced that the U.S. Food and Drug Administration (FDA) has approved Gazyva® (obinutuzumab) for adults with active lupus nephritis (LN) who are undergoing standard therapy. Eligible patients can also benefit from a shortened 90-minute infusion after the initial dose. Following four doses in the first year, Gazyva can be administered twice annually, offering a potentially more convenient approach compared with traditional targeted treatments.
“People with lupus nephritis who achieve a complete renal response are more likely to experience preserved kidney function and delay, or even prevention, of progression to end-stage kidney disease,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “The approval of Gazyva by the FDA marks an important step towards a potential new standard of care for lupus nephritis, one that could allow clinicians to offer their patients more effective disease control.”
Louise Vetter, President and CEO of the Lupus Foundation of America, highlighted the impact of the condition on patients’ lives: “As a severe and potentially life-threatening disease, lupus nephritis greatly disrupts daily life with chronic pain, fatigue, and the constant fear of worsening kidney health. The FDA’s approval of Gazyva offers renewed hope for people with lupus nephritis and their loved ones, as it provides an important new treatment option that has the potential to prevent long-term complications, including kidney failure.”
The FDA’s decision is supported by results from the Phase II NOBILITY and Phase III REGENCY studies. In the REGENCY trial, 46.4% of patients receiving Gazyva with standard therapy reached a complete renal response (CRR), compared with 33.1% who received standard therapy alone. Alongside this, participants showed better complement levels, lower anti-dsDNA, reduced corticosteroid use, and less proteinuria, all pointing to stronger disease control. Gazyva’s safety profile stayed in line with what has been seen in its hematology-oncology use.
More than 1.7 million people around the world are affected by lupus nephritis. It hits women hardest, especially women of color and those of childbearing age, who often have more severe disease. If left untreated, about a third of patients can progress to end-stage kidney disease, which usually means dialysis or a kidney transplant.
Gazyva received Breakthrough Therapy Designation from the FDA in 2019, based on the Phase II NOBILITY data. The European Medicines Agency’s CHMP recently issued a positive opinion recommending its approval for adults with active lupus nephritis, with a final decision from the European Commission expected soon.
Beyond lupus nephritis, Gazyva is under investigation for systemic lupus erythematosus, membranous nephropathy, idiopathic nephrotic syndrome, and pediatric lupus nephritis. Genentech continues to advance a broad pipeline targeting immune drivers of both rare and common kidney-related diseases.
