FDA Approves Roche’s Biogen-Partnered Gazyva for Lupus Nephritis
Gazyva (obinutuzumab), developed by Roche and partnered with Biogen, received FDA approval on October 20, 2025, for the treatment of adults with active lupus nephritis who are receiving standard therapy156.
This is the first anti-CD20 monoclonal antibody with Phase III evidence to show significant improvement in complete renal response, marking a notable advancement in treating this serious kidney complication of lupus23.
The approval was supported by data from the Phase III REGENCY study, which demonstrated that adding Gazyva to standard therapy significantly improved kidney outcomes compared to standard treatment alone2.
Lupus nephritis is a leading cause of kidney failure in people with lupus, and this new treatment may help reduce progression to end-stage renal disease23.
Gazyva was previously granted Breakthrough Therapy Designation by the FDA in 2019 based on earlier clinical data4.
Sources:
1. https://www.lupus.org/news/fda-approves-gazyva-obinutuzumab-for-treatment-of-adults-with-lupus-nephritis
2. https://www.pharmanow.live/latest-news/fda-reviews-roches-gazyva-for-lupus
3. https://www.lupusresearch.org/lupus-research-alliance-applauds-u-s-fda-approval-of-gazyva-obinutuzumab-for-lupus-nephritis/
4. https://www.biospace.com/press-releases/fda-approves-roches-gazyva-gazyvaro-for-the-treatment-of-lupus-nephritis
5. https://firstwordpharma.com/story/6326153
6. https://www.stocktitan.net/news/RHHBY/fda-approves-roche-s-gazyva-gazyvaro-for-the-treatment-of-lupus-ryu6qz0qtoix.html