Overview
- The approval covers adults with active lupus nephritis receiving standard therapy, making Gazyva the second biologic available for this condition in the U.S.
- The label permits four initial doses in the first year followed by twice‑yearly maintenance dosing, with an option for a 90‑minute infusion after the first administration in eligible patients.
- In the Phase 3 REGENCY trial, 46.4% on Gazyva plus standard care achieved complete renal response compared with 33.1% on standard care alone.
- Efficacy signals also included improved complement levels, reduced anti‑dsDNA antibodies, lower proteinuria, and decreased corticosteroid use among treated patients.
- Patient advocacy groups praised the decision, and Genentech noted ongoing studies in systemic lupus erythematosus, pediatric lupus nephritis, membranous nephropathy, and idiopathic nephrotic syndrome.