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

What happened: The European Medicines Agency's CHMP recommended approval of Roche's Gazyva/Gazyvaro (obinutuzumab) as an add-on therapy for adults with moderate-to-severe, active, autoantibody-positive systemic lupus erythematosus despite standard therapy. Why it matters: If approved, Gazyva/Gazyvaro would be the first glycoengineered, Type II anti-CD20 therapy for SLE, which Roche says could potentially become the new standard of care. The FDA accepted Roche's supplemental Biologics License Application for SLE earlier this year.

The European Medicines Agency's CHMP recommended approval of Roche's Gazyva/Gazyvaro (obinutuzumab) as an add-on therapy for adults with moderate-to-severe, active, autoantibody-positive systemic lupus erythematosus despite standard therapy.

If approved, Gazyva/Gazyvaro would be the first glycoengineered, Type II anti-CD20 therapy for SLE, which Roche says could potentially become the new standard of care. The FDA accepted Roche's supplemental Biologics License Application for SLE earlier this year.