Lupus Nephritis

This FDA News Month in Review provides a round-up of regulatory decisions from June 2025.

An audio recap of the top 5 stories in healthcare news from the week of 06/16-06/22

Stay updated with the latest healthcare breakthroughs, including new phase 2/3 clinical trial data and an FDA approval, in this week's essential news roundup.

With the approval, children ≥ 5 years of age with active lupus nephritis will have a first-of-its-kind treatment option for at-home administration.

Recent studies reveal belimumab's effectiveness in treating lupus nephritis, showing significant renal response and improved patient outcomes in real-world settings.

New analysis reveals obinutuzumab's potential to improve kidney inflammation and biomarkers in lupus nephritis.

The filing acceptance is based on positive data from the phase 3 REGENCY study. A decision on the approval is expected by October 2025.

Use of obinutuzumab was associated with significant improvements in complete renal response rate and markers of disease activity in active lupus nephritis.

ADI-001 now has FDA Fast Track Designation for relapsed/refractory lupus nephritis and systemic lupus erythematosus with extrarenal involvement.

The GLEAM trial is currently enrolling patients to receive SC291, with data expected in 2025.

Hypovitaminosis D was more prevalent in patients with lupus nephritis compared to patients with systemic lupus erythematosus without kidney disease.

Two patients with autoimmune diseases from 2 phase ½ RESET trials had complete B cell depletion within 15 days post-infusion with CABA-201 and needed no additional medication.

A propensity score matched analysis suggests use of SGLT2 inhibitors could reduce risk of negative outcomes in patients with systemic lupus erythematosus and type 2 diabetes.

Data presented at NKF Spring Clinical Meeting suggest events including myocardial infarction and stroke are more prevalent among patients with lupus in North America.

FDA approves label update for voclosporin (Lupkynis) in lupus nephritis, reflecting long-term AURORA data and new kidney function monitoring guidance.

The progression toward more targeted, disease-modifying options for the historically difficult rheumatic disease made more headway in 2023.

Throughout 2023, interest in the application of CAR-T and other cell therapies to autoimmune disease skyrocketed, with a multitude of clinical trials being initiated by various companies.

This research into improving quality measures for lupus patients was presented at ACR 2023 and funded by the CDC.

This research into obinutuzumab may provide some hope for those facing the most common cause of kidney damage among patients with lupus.

An analysis of data from 26 patients with repeat kidney biopsies in the AURORA program suggests voclosporin (Lupkynis) reduces proteinuria without causing harm in lupus nephritis patients.

Significantly more patients receiving voclosporin had a good renal outcome, defined as achieving adequate response with no renal flare, compared with controls.

Most patients with lupus nephritis reported moderate anxiety and moderate depression which impacted their disease activity and quality of life.

An analysis of data from the phase 2 AURA-LV and phase 3 AURORA 1 trials provides new insight into the effects of voclosporin for the treatment of active lupus nephritis in patients with high proteinuria.

An analysis of data obtained from urine samples in the MUSE and TULIP-1 trial sheds new light on the clinical utility of the RAIL score for identifying disease activity and treatment responders in SLE patients with and without lupus nephritis, respectively