CHMP recommends EU approval of Roche’s Gazyva/Gazyvaro for systemic lupus erythematosus (SLE)

Basel, 13 November 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Gazyva®/Gazyvaro® (obinutuzumab) as an add-on therapy for the treatment of adult patients with moderate-to-severe, active, autoantibody-positive systemic lupus erythematosus (SLE) despite standard therapy. A final decision from the European Commission is expected in the near future. In addition, the US Food and Drug Administration (FDA) accepted Roche’s supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro in SLE earlier this year. This recommendation builds on a growing list of approvals across immune-mediated diseases for Gazyva/Gazyvaro, including active lupus nephritis (LN) in more than 65 countries and idiopathic nephrotic syndrome (INS) in the US.4