Global healthcare giant Roche has announced a breakthrough in its therapy for a rare kidney disease.

 

In primary membranous nephropathy (PMN), the company has said that its phase III MAJESTY study met its primary endpoint, with significantly more patients achieving complete remission at two years compared to standard treatment with tacrolimus.

 

“This is a landmark moment,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. 

 

“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.”

 

Primary membranous nephropathy is a chronic autoimmune disease that attacks the kidneys’ filtering units, affecting nearly 88,000 people in the EU and over 96,000 in the US. Up to 30% of patients develop kidney failure within a decade, requiring dialysis or transplantation and creating a heavy burden for families and healthcare systems.

 

The MAJESTY study enrolled 142 adults randomized to receive Gazyva/Gazyvaro or tacrolimus. In addition to the primary endpoint, key secondary outcomes showed significant benefits in overall remission at week 104 and complete remission at week 76. Safety results aligned with Gazyva/Gazyvaro’s established profile, with no new safety concerns identified.

 

Gazyva/Gazyvaro, a glycoengineered, anti-CD20 monoclonal antibody, has already shown success in lupus nephritis, systemic lupus erythematosus, and idiopathic nephrotic syndrome. This marks the fourth positive phase III trial supporting its potential in immune-mediated diseases.

 

Beyond PMN, Roche continues its broader mission in immunology and kidney disease. “Our aim is to continue delivering meaningful value for those affected, healthcare systems and society, and help address this growing public health burden,” the company said.