Posted by Michael Wonder on 18 Oct 2025
CHMP recommends EU approval of Roche’s Gazyva/Gazyvaro for lupus nephritis
17 October 2025 - Positive recommendation based on Phase 2 NOBILITY and Phase 3 REGENCY data showing Gazyva/Gazyvaro’s superiority over standard therapy alone.
Roche announced today that the EMA’s CHMP has recommended the approval of Gazyva/Gazyvaro (obinutuzumab) 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.
