Among adults with active lupus nephritis, obinutuzumab plus standard therapy was more efficacious than standard therapy alone in providing a complete renal response. (Funded by F. Hoffmann-La Roche; REGENCY ClinicalTrials.gov number, NCT04221477.).

FDA approval of Gazyva expands therapeutic options for lupus care

FDA approval of Gazyva expands therapeutic options for lupus care

FDA approval of Gazyva expands therapeutic options for lupus care

FDA approval of Gazyva expands therapeutic options for lupus care

FDA approval of Gazyva expands therapeutic options for lupus care

Die US-amerikanische Food and Drug Administration (FDA) hat Gazyva® (Obinutuzumab), entwickelt von Genentech, als neues Therapeutikum für Erwachsene mit Lupus-Nephritis (LN) – der lupusspezifischen Nierenerkrankung – zugelassen. Dieses monoklonale Anti-CD20-Antikörper zielt auf B-Zellen ab, die Entzündungen und Nierenschäden fördern, und erweitert erheblich die Behandlungsoptionen für bis zu 60 Prozent der Lupus-Patienten, die an LN erkranken. Die Zulassung basiert auf Phase-III-Daten, die eine Verdopplung der vollständigen Nierenremission im Vergleich zur Standardtherapie zeigen und das Risiko für Nierenversagen senken.

Get the answers to questions about Gazyva® (obinutuzumab), a treatment for lupus nephritis, including how it works, side effects, and who it will work for.

The U.S. Food and Drug Administration (FDA) has approved Gazyva® (obinutuzumab), developed by Genentech, as a treatment for adults with lupus nephritis (LN), also known as lupus-related kidney disease...

The U.S. Food and Drug Administration (FDA) has approved Gazyva® (obinutuzumab), developed by Genentech, as a treatment for adults with lupus nephritis (LN), also known as lupus-related kidney disease...

FDA approval based on superiority of Gazyva/Gazyvaro over standard therapy alone, as shown in phase II NOBILITY and phase III REGENCY data1,2Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibod...