Also known as CellCept.
Phase 2 trial compares pegrizeprument with tacrolimus in up to 120 de novo kidney transplant recipients; primary endpoints are safety, pharmacokinetics and pharmacodynamics.
Phase 2 data show FcRn blocker nipocalimab reduced SLE activity versus placebo, with larger benefit in autoantibody‑positive patients and no new safety signals.
Phase III INShore showed improved sustained remission and steroid reduction versus MMF; no new safety signals, supporting a regulatory application.
Gazyva, combined with MMF, shows superior results in treating lupus nephritis, potentially delaying end-stage kidney disease, based on phase II and III studies.
Gazyva achieved sustained remission in young nephrotic syndrome patients, reducing steroid use. No new safety issues. Data to be shared with health authorities.
FDA approves Gazyva for lupus nephritis, showing superior results in trials, offering a new treatment option to prevent kidney disease progression.
CHMP backs Gazyva/Gazyvaro for lupus nephritis, showing superior renal response in trials. Awaiting European Commission decision.
