Genentech Reports the FDA's sBLA Acceptance for Gazyva to Treat Lupus Nephritis
Shots:
- Based on positive results from P-III (REGENCY) study, the US FDA has accepted sBLA of Gazyva in Lupus Nephritis; FDA's approval decision is expected by Oct’25
- The P-III (REGENCY) study demonstrated improved CRR with Gazyva + standard therapy vs standard therapy alone, along with improvements in complement levels & reductions in anti-dsDNA, markers of disease activity, and inflammation. Data was presented at the WCN and published in the NEJM in Feb'25
- Gazyva is a type II engineered anti-CD20 mAB. Same clinical data will be used to file submission with the EMA
Ref: Genentech | Image: Genentech
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