EU Medicines Agency Backs Expanded Use of Roche's Gazyvaro for Systemic Lupus Erythematosus

06:53 AM EST, 11/13/2026 (MT Newswires) -- The European Medicines Agency recommended expanding the approved use of Roche's (ROG.SW) Gazyvaro for moderate to severe active systemic lupus erythematosus, an autoimmune disease that mainly affects women. The positive opinion covers the use of Gazyvaro, or obinutuzumab, as an add-on treatment for patients who test positive for certain antibodies and whose disease remains active despite standard therapy, according to a Friday filing. The decision is supported by a study with 303 adult patients, in which 76.7% of those who received Gazyvaro plus standard therapy responded after 52 weeks of treatment versus 53.5% in the placebo arm. The European Commission will now decide whether to extend the drug's marketing authorization.