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Roche Wins FDA Nod For Gazyva/Gazyvaro In Lupus Nephritis Following Phase II NOBILITY And Phase III REGENCY Results

Author: Benzinga Newsdesk | October 20, 2025 01:38am

FDA approval based on superiority of Gazyva/Gazyvaro over standard therapy alone, as shown in phase II NOBILITY and phase III REGENCY data1,2
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
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

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