Posted by Michael Wonder on 20 Oct 2025
FDA approves Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
20 October 2025 - FDA approval based on superiority of Gazyva/Gazyvaro over standard therapy alone, as shown in Phase 2 NOBILITY and Phase 3 REGENCY data.
Roche announced today that the US FDA has approved Gazyva/Gazyvaro (obinutuzumab) for the treatment of adult patients with active lupus nephritis who are receiving standard therapy, as well as a shorter 90 minute infusion time after the first infusion, for eligible patients.
