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 ptsApproval was based on P-II (NOBILITY) & P-III (REGENCY) trials, where in REGENCY (n=271), 46.4% on Gazyva + SoC achieved…
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…

