{"id":62053,"date":"2025-10-20T07:05:22","date_gmt":"2025-10-20T05:05:22","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/fda-approves-genentechs-gazyva-for-the-treatment-of-lupus-nephritis\/"},"modified":"2025-10-20T07:05:22","modified_gmt":"2025-10-20T05:05:22","slug":"fda-approves-genentechs-gazyva-for-the-treatment-of-lupus-nephritis","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/fda-approves-genentechs-gazyva-for-the-treatment-of-lupus-nephritis\/","title":{"rendered":"FDA Approves Genentech\u2019s Gazyva for the Treatment of Lupus Nephritis"},"content":{"rendered":"
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\n\u2013 FDA approval based on superiority of Gazyva over standard therapy alone, as shown in Phase II NOBILITY and Phase III REGENCY data \u2013<\/i><\/p>\n

\n\u2013 Gazyva is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomized Phase III study \u2013<\/i><\/p>\n

\n\u2013 Lupus nephritis affects more than 1.7 million people worldwide, predominantly women of color and childbearing age, with up to one third of patients progressing to end-stage kidney disease \u2013<\/i><\/p>\n

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Gazyva\u00ae<\/sup> (obinutuzumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy, as well as a shorter 90-minute infusion time after the first infusion, for eligible patients. Following four initial doses in the first year, Gazyva can be administered twice yearly, offering an effective and potentially more convenient treatment option than traditional targeted therapies.<\/p>\n

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\n\u201cPeople 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,\u201d said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. \u201cThe 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.\u201d<\/p>\n

\n\u201cAs 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,\u201d said Louise Vetter, President and Chief Executive Officer, Lupus Foundation of America. \u201cThe FDA\u2019s 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.\u201d<\/p>\n

\nThis 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.<\/p>\n

\nLupus 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.<\/p>\n

\nGazyva was granted Breakthrough Therapy Designation by the FDA in 2019 based on data from the Phase II NOBILITY study. The European Medicines Agency\u2019s 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.<\/p>\n

\nGazyva 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.<\/p>\n

\nAbout Gazyva<\/b><\/p>\n

\nGazyva\u00ae<\/sup> (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.<\/p>\n

\nGazyva 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.<\/p>\n

\nAbout the REGENCY Study<\/b><\/p>\n

\nREGENCY [NCT04221477<\/a>] is a Phase III, randomized, double-blind, placebo-controlled, multicenter study investigating the efficacy and safety of Gazyva\u00ae<\/sup> (obinutuzumab) plus standard therapy (mycophenolate mofetil and glucocorticoids) in people with active\/chronic International Society of Nephrology\/Renal Pathology Society 2003 proliferative Class III or IV lupus nephritis, with or without Class V. The study enrolled 271 people, who were randomized 1:1 to receive either Gazyva plus standard therapy or placebo plus standard therapy. REGENCY was designed based on robust Phase II data<\/a> and conducted during the COVID-19 pandemic. The study population was representative of the real-world population of people with lupus nephritis.<\/p>\n

\nAbout Lupus Nephritis<\/b><\/p>\n

\nLupus 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.<\/p>\n

\nLupus nephritis affects more than 1.7 million people worldwide – predominantly women, mostly of color and usually of childbearing age. Currently, there is no cure.<\/p>\n

\nIndication<\/b><\/p>\n

\nGAZYVA\u00ae<\/sup> (obinutuzumab) is indicated for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy<\/p>\n

\nImportant Safety Information<\/b><\/p>\n

\nThe most important safety information patients should know about GAZYVA<\/b><\/p>\n

\nPatients must tell their doctor right away about any side effect they experience. GAZYVA can cause side effects that can become serious or life-threatening, including:<\/p>\n