Roche reports MAJESTY study met primary endpoint

Roche (RHHBY) announced that the Phase 3 MAJESTY study in adults with primary membranous nephropathy met its primary endpoint, showing statistically significant and clinically meaningful results with Gazyva/Gazyvaro. Results show that significantly more people achieved complete remission at two years with Gazyva/Gazyvaro versus tacrolimus. Safety was in line with the well-characterized profile of Gazyva/Gazyvaro and no new safety signals were identified. Analysis of key secondary endpoints showed statistically significant and clinically meaningful benefits with Gazyva/Gazyvaro versus tacrolimus in overall remission at week 104 and complete remission at week 76. Data 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, the company stated. “These results demonstrate that Gazyva/Gazyvaro may help more people with primary membranous nephropathy achieve complete remission, maintain kidney function for longer and delay or potentially prevent the onset of life-threatening complications. If approved, Gazyva/Gazyvaro would be the first therapy specifically indicated for people with primary membranous nephropathy, where there are limited treatment options,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development.