Health
FDA approves Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
FDA approval based on superiority of Gazyva/Gazyvaro over standard therapy alone, as shown in phase II NOBILITY and phase III REGENCY data1,2Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study2Lupus nephritis affects more than 1.7 million people worldwide, predominantly women of colour and childbearing age, with up to one-third of patients progressing to end-stage kidney disease3-6 Basel, 20
About this update from Roche Holding Ltd
[{"type":"image","alt":"F. Hoffmann-La Roche Ltd","displaySize":"","headline":null,"caption":"F. Hoffmann-La Roche Ltd","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":198,"url":"https://media.zenfs.com/en/globenewswire.com/d295bae68c32358ba6ac888e76c1cca2"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/TdqKHuoAMRswPfW7YQ22wg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTI3NztjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/d295bae68c32358ba6ac888e76c1cca2","width":300,"height":198}},"lazy":false},{"type":"list","items":[{"val":[{"type":"text","content":"FDA approval based on superiority of Gazyva/Gazyvaro over standard therapy alone, as shown in phase II NOBILITY and phase III REGENCY data1,2","length":141,"tagName":"p"}]},{"val":[{"type":"text","content":"Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study2","length":158,"tagName":"p"}]},{"val":[{"type":"text","content":"Lupus nephritis affects more than 1.7 million people worldwide, predominantly women of colour and childbearing age, with up to one-third of patients progressing to end-stage kidney disease3-6","length":191,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":490,"olType":false},{"type":"text","content":"Basel, 20 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved Gazyva®/Gazyvaro®(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/Gazyvaro can be administered twice yearly, offering an effective and potentially more convenient treatment option than traditional targeted therapies.","length":572,"tagName":"p"},{"type":"text","content":"“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, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “The approval of Gazyva/Gazyvaro by the FDA marks an important step towards a potential new standard of care for lupus nephriti...