Swiss biotech MNC Roche has announced that the European Commission has approved its drug to treat adults with active lupus nephritis, a serious kidney complication of lupus.

 

The nod is for Gazyva/Gazyvaro (obinutuzumab) in combination with mycophenolate mofetil (MMF) for adults with active Class III or IV lupus nephritis, the company has said.

 

“This approval marks a major advance in the treatment of lupus nephritis for people across Europe who wrestle with this disease,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “By controlling disease activity, Gazyva/Gazyvaro could help delay or prevent progression to end-stage kidney disease and the need for dialysis or transplant, underscoring its potential to become a new standard of care in Europe.”

 

The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies. 

 

REGENCY, published in the New England Journal of Medicine, showed 46.4% of patients on Gazyva/Gazyvaro plus standard therapy achieved complete renal response, compared to 33.1% on standard therapy alone. 

 

The data also highlighted reduced corticosteroid use, improved proteinuric response, better complement levels, and lower anti-dsDNA antibodies, signaling meaningful disease control. Safety results aligned with Gazyva/Gazyvaro’s established haematology-oncology profile.

 

“The symptoms of lupus nephritis and their unpredictable nature can impact quality of life, emotional wellbeing and limit future family and career prospects,” said Jeanette Andersen, Chair of Lupus Europe. “This approval for Gazyva/Gazyvaro offers a much needed treatment that may help ease the burden of living with this complex disease and reflects the vital role of patient community experts in trial development.”

 

Lupus nephritis predominantly affects women of color of childbearing age, with an estimated 135,000 patients across the EU.