New EC approval for Roche’s Gazyva/Gazyvaro

The European Commission has approved Roche’s (ROG: SIX) Gazyva/Gazyvaro (obinutuzumab) in combination with mycophenolate mofetil (MMF) for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis. These disease classifications describe the extent and nature of damage to the kidneys and renal function, a key characteristic of lupus nephritis.

“This approval marks a major advance in the treatment of lupus nephritis for people across Europe who wrestle with this disease,” said Dr Levi Garraway, Roche’s chief medical officer and head of global product development, noting that, 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.

Clinical backing