Gazyva Shows Promising Results in Lupus Nephritis Treatment, Paving Way for Expanded Indication

Study Success:
The Phase III REGENCY study of Gazyva (obinutuzumab) in patients with active lupus nephritis has met its primary endpoint, demonstrating statistically significant and clinically meaningful treatment benefits.

Complete Renal Response:
A higher proportion of patients treated with Gazyva plus standard therapy achieved a complete renal response (CRR) at 76 weeks compared to those treated with standard therapy alone.

Secondary Endpoints: Gazyva also showed superiority in two key secondary endpoints:
the proportion of patients achieving CRR with a successful reduction in corticosteroid use, and an improvement in proteinuric response.

Mechanism of Action:
Gazyva targets the CD20 surface protein on B cells, leading to their depletion and potentially preventing or delaying progression to end-stage kidney disease.

Regulatory Submission:
Data from the REGENCY study will be shared with health authorities, including the FDA and the European Medicines Agency, for potential approval in the treatment of lupus nephritis.

Disease Impact:
Lupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus (SLE), affecting approximately 1.7 million people worldwide, with up to a third progressing to end-stage kidney disease within 10 years.