Roche’s Phase III ALLEGORY trial reveals that Gazyva plus standard therapy helped 76.7% of SLE patients achieve significant clinical improvement. New data published in NEJM highlights Gazyva’s potential to redefine the standard of care in lupus by preventing organ damage and reducing steroid dependency.
In a landmark announcement, Roche revealed that Gazyva (obinutuzumab) met its primary endpoint in the phase III MAJESTY trial for primary membranous nephropathy treatment. The trial data demonstrates superior clinical outcomes compared to tacrolimus, positioning Gazyva as a transformative therapy for patients with this chronic autoimmune kidney condition. With nearly 88,000 affected patients in the EU and over 96,000 in the US, primary membranous nephropathy represents a significant unmet medical need. Gazyva phase III results show the potential to become the first FDA and EMA-approved therapy specifically for this indication. The positive MAJESTY trial outcomes highlight Gazyva’s mechanism deep tissue B cell depletion via anti-CD20 targeting as an effective approach to halting disease progression and preserving kidney function in primary membranous nephropathy patients.
Roche’s Phase III ALLEGORY study for Gazyva® (obinutuzumab) in systemic lupus erythematosus (SLE) met its primary and all key secondary endpoints. These “unprecedented” results demonstrate Gazyva’s potential to effectively control disease activity and may delay or prevent further organ damage in people with SLE.
Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Gazyva/Gazyvaro (obinutuzumab) for the treatment of adult patients with active lupus nephritis. Based on positive results from Phase II and III clinical trials, this new therapy offers a significant advancement for those suffering from this severe kidney complication of lupus, showing superiority over standard therapy alone.
