Shots:
- The US FDA has approved Gazyva (4 initial dose then Q6M) for the treatment of adults with lupus nephritis who are on SoC & also allowing a shorter 90min. infusion after the first dose for eligible pts
- Approval was based on P-II (NOBILITY) & P-III (REGENCY) trials, where in REGENCY (n=271), 46.4% on Gazyva + SoC achieved CRR vs 33.1% on SoC & showed improved complement levels & decreased anti-dsDNA, corticosteroid use, & proteinuria
- Gazyva is an anti-CD20 mAb, which is being studied for systemic lupus erythematosus, membranous nephropathy, idiopathic nephrotic syndrome, & in children & adolescents with lupus nephritis
Ref: Genentech| Image: Genentech| Press Release
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