CHMP recommends EU approval of Roche’s Gazyva/Gazyvaro for lupus nephritis

Roche (RHHBY) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of Gazyva/Gazyvaro in combination with mycophenolate mofetil for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis. A final decision from the European Commission is expected in the near future. “As the only anti-CD20 to demonstrate a complete renal response benefit in a randomized phase III study of lupus nephritis, Gazyva/Gazyvaro has the potential to address an important unmet need for many people with this disease. Recognizing the challenges faced by people with lupus nephritis and their caregivers, Gazyva/Gazyvaro may offer a new treatment option that can limit kidney damage and potentially prevent or delay end-stage kidney disease,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development.