Genentech, a member of the Roche Group, has introduced a groundbreaking medicine called Gazyva® (obinutuzumab) for the treatment of lupus nephritis in adults.
Gazyva is an innovative monoclonal antibody designed to target CD20, a specific protein found on certain types of B-cells.
The U.S. Food and Drug Administration granted breakthrough designation to Gazyva based on data from the phase II NOBILITY study, which involved adult patients with proliferative lupus nephritis.
Results from the clinical trial demonstrated that the combination of obinutuzumab with mycophenolate mofetil or mycophenolic acid and corticosteroids resulted in a higher number of complete renal responses compared to the standard care group in advanced lupus nephritis cases.
Lupus nephritis is a potentially life-threatening complication of systemic lupus erythematosus that arises from kidney inflammation and is associated with a high risk of end-stage renal disease or death.
In the NOBILITY trial, which enrolled 126 participants, the primary endpoint of achieving a complete renal response at 52 weeks, as well as the secondary endpoint of achieving complete and partial renal responses and improved disease activity markers, were successfully met by the sponsor.
No additional safety signals were reported.
