Roche's Gazyva Secures FDA Nod for Label Expansion in Lupus Nephritis

Core Insights - Roche's Gazyva/Gazyvaro has received FDA approval for the treatment of adult patients with active lupus nephritis (LN) who are on standard therapy [1][7] - The approval allows for shorter infusion times and fewer annual doses, enhancing treatment convenience [2][8] - The FDA's decision is based on positive results from Roche's phase II NOBILITY and phase III REGENCY studies, which showed significant renal response improvements [4][5] Regulatory Approval - Gazyva/Gazyvaro is already approved in 100 countries for various hematological cancers, and in the U.S., it is marketed in partnership with Biogen [3] - The FDA granted Breakthrough Therapy designation for Gazyva/Gazyvaro in the treatment of LN, with a similar filing under review in the EU [10] Clinical Study Results - The REGENCY study met its primary endpoint with statistical significance, showing nearly half of patients achieved a complete renal response at 76 weeks when treated with Gazyva/Gazyvaro and standard therapy [5][8] - Improvements in complement levels, reductions in anti-dsDNA, lower corticosteroid use, and decreased proteinuria were also observed, indicating better disease control [8] Market Performance - Year-to-date, Roche's shares have increased by 26.3%, outperforming the industry growth of 5.1% [6] Patient Demographics - Lupus nephritis affects approximately 1.7 million people globally, predominantly women of color in their childbearing years, with untreated patients at risk of advancing to end-stage kidney disease [9] Future Developments - Roche is evaluating Gazyva/Gazyvaro in clinical studies for treating children and adolescents with LN, as well as other kidney-related conditions [11]