Q2 2025 Recap: Nephrology News and Updates

Published on: July 5, 2025

The Q2 recap for nephrology spotlights key FDA decisions and top coverage from the 62nd European Renal Association Congress.

The second quarter of 2025 brought a flurry of regulatory activity and major clinical trial updates underscoring the rapidly evolving landscape in nephrology. From IgA nephropathy (IgAN) and C3 glomerulopathy (C3G) to lupus nephritis (LN) and focal segmental glomerulosclerosis (FSGS), a string of FDA actions—including multiple Priority Review designations, a novel autoinjector approval, and an accelerated approval for a new class of therapy in IgAN—signal increasing momentum for therapeutic innovation across a range of kidney diseases.

Meanwhile, the 62nd European Renal Association (ERA 2025) Congress served as a showcase for emerging data that could shape future standards of care. Highlights included 52-week results from VALIANT supporting pegcetacoplan’s benefit in C3G/primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), CONFIDENCE trial findings backing dual initiation of finerenone and empagliflozin in chronic kidney disease (CKD) and type 2 diabetes, and sibeprenlimab’s 51% proteinuria reduction in IgAN.

Here’s a recap of what made headlines in Q2 of 2025:

Renal FDA News

FDA Accepts Pegcetacoplan (Empaveli) sNDA for C3G, IC-MPGN

Starting Q2 on a high note, on April 1, 2025, Apellis Pharmaceuticals announced the FDA accepted and granted Priority Review designation to the Company’s supplemental New Drug Application (sNDA) for pegcetacoplan (Empaveli) for C3G and IC-MPGN. Supported by positive 26-week results from the phase 3 VALIANT trial, a Prescription Drug User Fee Act (PDUFA) target action date of July 28, 2025, has been assigned.

Atrasentan (Vanrafia) Receives Accelerated Approval in IgA Nephropathy

The next day, on April 2, 2025, the FDA granted accelerated approval to atrasentan (Vanrafia), a once-daily, non-steroidal, oral treatment, for reducing proteinuria in adults with primary IgAN at risk of rapid disease progression. Notably, the decision marked the FDA’s first approval for a selective endothelin A receptor antagonist for reducing protein in IgAN and came without any requirement for a Risk Evaluation Mitigation Strategy (REMS) program for use.

FDA Accepts Sparsentan (Filspari) sNDA for Focal Segmental Glomerulosclerosis

On May 15, 2025, the FDA accepted Travere Therapeutics’ sNDA for traditional approval of sparsentan (Filspari) for the treatment of FSGS, supported by results from the phase 3 DUPLEX Study and the phase 2 DUET Study. With the acceptance, the FDA assigned a PDUFA target action date of January 13, 2026, and indicated plans to hold an advisory committee meeting to discuss the application.

FDA Accepts, Grants Priority Review to Sibeprenlimab BLA for IgA Nephropathy

On May 27, 2025, the FDA accepted and granted priority review to Otsuka Pharmaceutical Development & Commercialization’s Biologics License Application (BLA) for sibeprenlimab for the treatment of IgAN, which was supported by data from the phase 3 VISIONARY trial and the phase 2 ENVISION trial. With the acceptance, the FDA assigned a PDUFA target action date of November 28, 2025.

FDA Approves Belimumab (Benlysta) Autoinjector for Pediatric Lupus Nephritis

On June 24, 2025, the FDA approved a 200 mg/mL autoinjector of GlaxoSmithKline’s belimumab (Benlysta), a B-lymphocyte stimulator-specific inhibiting monoclonal antibody, for subcutaneous injection in patients ≥ 5 years of age with active LN who are receiving standard therapy. Initially approved for pediatric patients with active systemic lupus erythematosus in 2024, the approval of the belimumab autoinjector for LN offers patients and caregivers a first-of-its-kind subcutaneous option that can be administered at home.

Top Nephrology News from ERA 2025

Pegcetacoplan Sustains Proteinuria Reductions in C3G, IC-MPGN at 52 Weeks

Extended data from the phase 3 VALIANT trial presented at ERA 2025 support the sustained efficacy and safety of pegcetacoplan (Empaveli) in patients with C3G or IC-MPGN, including adolescents and adults with native or transplanted kidneys. Specifically, the 52-week results show continued proteinuria reduction and eGFR stabilization in both treatment-naïve and crossover groups. An FDA decision on its approval for this indication is expected by July 28, 2025.

CONFIDENCE: SGLT2i and Finerenone Effective, Safe to Initiate Simultaneously in CKD

Findings from the CONFIDENCE trial presented at ERA 2025 suggest simultaneous initiation of finerenone (Kerendia) and empagliflozin (Jardiance) is well-tolerated and associated with a greater reduction in urinary albumin to creatinine ratio (UACR) than either therapy alone among patients with CKD and type 2 diabetes.

Sibeprenlimab Halves Proteinuria in IgAN in Phase 3 VISIONARY Trial

Findings from an interim analysis of the phase 3 VISIONARY trial show use of sibeprenlimab was associated with a 51.2% reduction in proteinuria at 9 months relative to placebo therapy among patients with IgAN, according to an interim analysis of the phase 3 VISIONARY trial. With its BLA acceptance in May, a decision on sibeprenlimab’s approval for IgAN is expected by November 28, 2025.