Roche’s Gazyva wins CHMP recommendation for EU approval in lupus
Roche received a positive EU regulatory recommendation for Gazyva/Gazyvaro as an add-on treatment for adults with moderate-to-severe active lupus despite standard therapy. A final European Commission decision is expected soon; the FDA accepted a supplemental application earlier this year.
1. EU recommendation
The recommendation, received on November 13, 2026, covers adults with moderate-to-severe, active, autoantibody-positive systemic lupus erythematosus despite standard therapy. A final European Commission decision is expected soon, and the FDA accepted a supplemental application earlier this year.
2. Trial findings
Previously reported phase III ALLEGORY results showed improved disease control, higher remission rates and reduced steroid use compared with placebo. The trial identified no new safety signals.
