Roche Reports Positive Phase III Results for Gazyva in Membranous Nephropathy
- Phase III MAJESTY study met its primary endpoint with Gazyva showing significant results.
- Complete remission achieved at two years with Gazyva versus tacrolimus.
- Safety profile of Gazyva consistent with no new safety signals identified.
- Data to be presented at a medical meeting and shared with FDA and EMA.
Study Results
The phase III MAJESTY study in adults with primary membranous nephropathy met its primary endpoint, demonstrating statistically significant and clinically meaningful results with Gazyva/Gazyvaro (obinutuzumab). The study showed that significantly more participants achieved complete remission at two years (104 weeks) with Gazyva compared to tacrolimus.
Safety Profile
The safety of Gazyva was consistent with its well-characterized profile, and no new safety signals were identified during the study.
Secondary Endpoints
Analysis of key secondary endpoints revealed statistically significant and clinically meaningful benefits with Gazyva over tacrolimus in overall remission (complete or partial) at week 104 and complete remission at week 76.
Next Steps
Data from the study will be presented at an upcoming medical meeting and shared with health authorities, including the US Food and Drug Administration and the European Medicines Agency.
Condition Overview
Primary membranous nephropathy is a chronic autoimmune condition that can cause irreversible kidney damage and reduced kidney function. It affects nearly 88,000 people in the EU and over 96,000 in the US. Up to 30% of those affected may develop kidney failure over 10 years, necessitating invasive interventions like dialysis or transplant, which have significant impacts on patients and healthcare systems.
Source: Roche