Roche's Active Lupus Nephritis Treatment Receives EU Approval

01:14 AM EST, 12/09/2025 (MT Newswires) -- Roche (ROG.SW) won approval from the European Commission for Gazyva/Gazyvaro to treat certain adult patients with lupus nephritis. The treatment was approved in combination with mycophenolate mofetil for patients with active class III or IV lupus nephritis, with or without concomitant class V, according to a Tuesday release. The Swiss pharmaceutical company said the authorization was based on positive results from the phase 2 Nobility and phase 3 Regency studies. In the Regency trial, 46.4% of the patients treated with Gazyva/Gazyvaro achieved a complete renal response, versus 33.1% among those on standard care alone. Gazyva/Gazyvaro is approved to treat active lupus nephritis in the US.