FDA Approves Obinutuzumab for Active Lupus Nephritis

“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.”

“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,” said Louise Vetter, President and Chief Executive Officer, Lupus Foundation of America. “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.”

This approval is based on positive results from the Phase II NOBILITY and Phase III REGENCY studies. In REGENCY, data showed that nearly half of the participants (46.4%) on Gazyva in combination with standard therapy achieved a complete renal response (CRR) compared to 33.1% on standard therapy alone. This was accompanied by clinically meaningful improvements in complement levels and reductions in anti-dsDNA, corticosteroid use, and proteinuria, all signaling improved disease control. The safety profile of Gazyva was consistent with the well-characterized profile observed in its hematology-oncology indications.

Lupus nephritis affects more than 1.7 million people worldwide. It disproportionately impacts women, mostly women of color and of childbearing age, who often face more severe disease. If left untreated, up to one-third of individuals can progress to end-stage kidney disease, which often requires dialysis or transplantation.

Gazyva was granted Breakthrough Therapy Designation by the FDA in 2019 based on data from the Phase II NOBILITY study. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recently issued a positive opinion recommending the approval of Gazyva for adults with active lupus nephritis, with a final decision from the European Commission expected in the near future.

Gazyva is being investigated in people with systemic lupus erythematosus, membranous nephropathy, idiopathic nephrotic syndrome, and in children and adolescents with lupus nephritis. In addition to Gazyva, Genentech has a broad pipeline targeting the immune drivers of rare and common kidney and kidney-related diseases.

About Gazyva

Gazyva® (obinutuzumab) is a Type II engineered humanized monoclonal antibody designed to attach to CD20, a protein found on certain types of B cells. In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys and reduces their ability to function properly. Data suggests that Gazyva depletes disease-causing B cells, helping to limit further damage to the kidneys and potentially preventing or delaying progression to end-stage kidney disease.

Gazyva is already approved in 100 countries for various types of hematological cancers. In the United States, Gazyva is part of a collaboration between Genentech and Biogen.

About Lupus Nephritis

Lupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus (SLE), an autoimmune disease that commonly affects the kidneys. Lupus nephritis is characterized by an irreversible loss of nephrons, the filtering structures of the kidneys. Periods of intense disease activity, known as flares, can speed up the loss of nephrons and be left unchecked, leading to a progressive loss of kidney function. Even with the latest treatments, up to a third of people will progress to end-stage kidney disease, where dialysis or transplant are the only options and life expectancy and quality of life are substantially reduced.

Lupus nephritis affects more than 1.7 million people worldwide - predominantly women, mostly of color and usually of childbearing age. Currently, there is no cure.