Roche (RHHBY) announced that the European Commission has approved Gazyva/Gazyvaro 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. The approval is based on positive results from the phase II NOBILITY and phase III REGENCY studies. This approval follows the Gazyva/Gazyvaro approval by the US Food and Drug Administration for the treatment of adults with active lupus nephritis who are receiving standard therapy in October 2025.
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