Genentech's Gazyva Shows Positive Phase III Results in Primary Membranous Nephropathy
- Phase III MAJESTY study met its primary endpoint with Gazyva in primary membranous nephropathy.
- Significant remission achieved at two years with Gazyva versus tacrolimus.
- No new safety signals identified; safety profile consistent with Gazyva.
- Data to be presented at a medical meeting and shared with FDA and EMA.
Study Results
The Phase III MAJESTY study demonstrated that Gazyva achieved statistically significant and clinically meaningful results in adults with primary membranous nephropathy. More participants reached complete remission at two years with Gazyva compared to tacrolimus.
Safety Profile
The safety of Gazyva was consistent with its established profile, and no new safety signals were identified during the study.
Secondary Endpoints
Key secondary endpoints showed significant benefits with Gazyva in overall remission at week 104 and complete remission at week 76.
Future Steps
Data from the study will be presented at an upcoming medical meeting and shared with health authorities, including the U.S. Food and Drug Administration and the European Medicines Agency.
Impact on Disease
Primary membranous nephropathy is a chronic autoimmune condition affecting over 96,000 people in the U.S., with up to 30% developing kidney failure over 10 years. Gazyva targets an underlying cause, potentially maintaining kidney function longer and preventing severe complications.
Previous Studies
MAJESTY is the fourth positive Phase III study of Gazyva in immune-mediated diseases, following successful trials in lupus nephritis, systemic lupus erythematosus, and idiopathic nephrotic syndrome.
Source: Genentech