Nephrology Month in Review: March 2025

March was a significant month for the field of nephrology, characterized by key US Food and Drug Administration (FDA) decisions and broader recognition of the growing chronic kidney disease (CKD) crisis.

In honor of National Kidney Month, a 2-part Crisis Point episode spotlighted the growing burden of CKD and the urgent need for action. Meanwhile, the FDA made notable moves across the nephrology landscape, including the approval of oral iptacopan (Fabhalta) as the first treatment for C3 glomerulopathy (C3G) and furosemide injection (Furoscix) for edema in CKD. Beyond approvals, regulatory progress continued with filings and acceptances in lupus nephritis, IgA nephropathy (IgAN), and focal segmental glomerulosclerosis (FSGS).

Check out this March 2025 nephrology month in review for a recap of HCPLive’s coverage of the top renal news and research from the past few weeks:

Observing National Kidney Month

In honor of March being National Kidney Month, the latest episode of Crisis Point addresses the growing burden of CKD and its emergence as the most significant public health crisis of our time. The 2-part episode features insight from a trio of nephrology experts and a patient advocate:

• Pranav Garimella, MBBS, MPH, chief medical officer of the American Kidney Fund
• Joseph Vassalotti, MD, associate clinical professor of medicine in the division of nephrology at Icahn School of Medicine at Mount Sinai and chief medical officer of the National Kidney Foundation
• Salvatore Viscomi, MD, chief executive officer of Carna Health
• Aja Best, MBA, a patient advocate who was diagnosed with CKD during pregnancy, eventually requiring dialysis and a kidney transplant

Part 1: Crisis Point: The Silent Rise and Growing Threat of Chronic Kidney Disease

Part 2: Crisis Point: Curbing the Chronic Kidney Disease Epidemic

FDA News in Nephrology

Travere Therapeutics Submits sNDA for Sparsentan (Filspari) in FSGS

On March 17, 2025, Travere Therapeutics announced the submission of a supplemental New Drug Application (sNDA) seeking priority review for traditional approval of sparsentan (Filspari) for the treatment of FSGS. Already boasting accelerated approval for the reduction of proteinuria in IgAN, the submission for FSGS is supported by results from the phase 3 DUPLEX Study and the phase 2 DUET Study, described by Travere as 2 of the largest head-to-head interventional studies conducted to date in adult and pediatric patients with FSGS.

Otsuka Files BLA for Sibeprenlimab for IgA Nephropathy

Later in the month, Otsuka Pharmaceutical announced the filing of a Biologics License Application (BLA) for sibeprenlimab in adults with IgAN, supported by results from the phase 2 ENVISION and the phase 3 VISIONARY clinical trials.

“Sibeprenlimab’s unique mechanism of action inhibits the activity of APRIL and addresses an IgA-specific driver of kidney loss in IgA nephropathy. APRIL is a cytokine that plays a key role in the pathogenesis of IgA nephropathy and we are optimistic about its potential to be an important treatment option for this progressive kidney disease,” said John Kraus, MD, PhD, executive vice president and chief medical officer of Otsuka.

FDA Accepts Obinutuzumab (Gazyva/Gazyvaro) sBLA for Lupus Nephritis

The FDA accepted Roche’s supplemental BLA for obinutuzumab (Gazyva/Gazyvaro) for the treatment of lupus nephritis based on positive results from the phase 3 REGENCY study, which showed improved complete renal response with obinutuzumab plus standard therapy compared with standard therapy alone.

According to a March 5, 2025, release from the company, the FDA is expected to make a decision on approval by October 2025.

FDA Approves Furosemide Injection (Furoscix) for Edema in CKD

The first renal FDA approval of the month was granted to scPharmaceuticals’ supplemental New Drug Application (sNDA) for furosemide (Furoscix), expanding its indication to include the treatment of edema in patients with CKD. The expanded indication means furosemide injection, 80 mg/10 mL for subcutaneous use is now approved for the treatment of edema, including congestion, fluid overload, or hypervolemia, in adult patients with chronic heart failure or CKD, including nephrotic syndrome.

FDA Approves Oral Iptacopan (Fabhalta) as First C3 Glomerulopathy Therapy

The second approval of the month was a historic one, with Novartis’ oral iptacopan (Fabhalta) becoming the first-ever FDA-approved treatment for C3G.

“C3G is a debilitating disease often affecting young people, impacting many aspects of their physical and emotional health, and our previous treatment options came with significant challenges,” said APPEAR-C3G study co-investigator Carla Nester, MD, MSA, professor of pediatrics-nephrology at the University of Iowa. “This approval of Fabhalta is historic for the entire C3G community as now, for the first time, we have a therapy that is believed to treat the underlying cause of the disease, providing the potential for a new standard of care for patients.”

Related: Expert Perspectives: Iptacopan FDA Approval for C3 Glomerulopathy