“Revolutionizing Lupus Nephritis Treatment: Roche’s Gazyva/Gazyvaro Proven Superior to Standard Therapy in New England Journal of Medicine Study”

Roche’s Gazyva Shows Promise in Treating Lupus Nephritis

Basel, 7 February 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that a detailed analysis of its phase III REGENCY trial of Gazyva®/Gazyvaro® (obinutuzumab) in people with active lupus nephritis (LN) was published in the New England Journal of Medicine.

The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of complete renal response (CRR), showing that 46.4% of people treated with Gazyva/Gazyvaro plus standard therapy (mycophenolate mofetil and glucocorticoids) achieved CRR at 76 weeks compared with 33.1% of people treated with standard therapy alone. This was accompanied by clinically meaningful improvements in complement levels and reductions in anti-dsDNA, markers of disease activity and inflammation.

Impact on Individuals:

For individuals suffering from lupus nephritis, the findings from Roche’s REGENCY trial offer hope for improved outcomes and quality of life. The increased rate of complete renal response and reduction in disease activity markers signify a significant advancement in treatment options for this challenging condition. Patients may benefit from a more effective and targeted approach to managing their symptoms, leading to better long-term prognosis and well-being.

Global Impact:

On a larger scale, Roche’s success in the development of Gazyva for lupus nephritis has the potential to revolutionize the way autoimmune diseases are treated. This breakthrough not only represents a significant achievement in medical research but also paves the way for future innovations in the field of immunology. The findings of the REGENCY trial may inspire further studies and collaborations aimed at addressing other complex autoimmune disorders, ultimately improving healthcare outcomes on a global scale.

Conclusion:

Roche’s publication of the REGENCY trial results in the New England Journal of Medicine marks a significant milestone in the treatment of lupus nephritis. The promising outcomes of Gazyva/Gazyvaro offer new hope for individuals battling this challenging condition, while also signaling a positive shift in the landscape of autoimmune disease management. As we look towards the future, it is clear that this advancement has the potential to make a lasting impact on both individual lives and global healthcare practices.

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