Image soure: Shutterstock

Highlights

  • FDA Accelerated Approval: Vanrafia® (atrasentan) has been approved for reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression.

  • Phase III ALIGN Study: Approval is based on interim data from a clinical trial showing proteinuria reduction at 36 weeks. Full results, including kidney function impact, are expected in 2026.

  • Novartis Expands Kidney Disease Portfolio: This marks the third FDA approval in the past year, following Fabhalta®'s approvals for C3 glomerulopathy and IgAN.

Novartis has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Vanrafia® (atrasentan), a potent and selective endothelin A (ETA) receptor antagonist, for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at high risk of rapid disease progression. The approval is based on interim results from the Phase III ALIGN study, which demonstrated a significant reduction in urine protein-to-creatinine ratio (UPCR) at 36 weeks compared to placebo.

Vanrafia is a once-daily, non-steroidal, oral treatment that can be used alongside renin-angiotensin system (RAS) inhibitors with or without a sodium-glucose co-transporter-2 (SGLT2) inhibitor. However, it is not yet established whether Vanrafia slows kidney function decline, and its continued approval depends on further clinical validation. The ongoing ALIGN study will assess whether the drug slows disease progression, measured by estimated glomerular filtration rate (eGFR) decline at week 136, with results expected in 2026.

Understanding IgA Nephropathy

IgAN is a progressive, rare autoimmune kidney disease that leads to glomerular inflammation and proteinuria, often resulting in kidney failure over time. In the United States, approximately 13 per million people are diagnosed annually. Without effective treatment, up to 50% of patients with persistent proteinuria progress to kidney failure within 10 to 20 years, often requiring dialysis or kidney transplantation. Treatment responses vary, making targeted therapies like Vanrafia essential for personalized care.

Novartis' Growing Kidney Disease Portfolio

Vanrafia's approval marks Novartis' third major U.S. regulatory success in kidney disease treatments within the past year. In March 2025, Fabhalta® received FDA approval for C3 glomerulopathy (C3G), followed by an accelerated approval for IgAN in August 2024. The company is also conducting trials for Fabhalta in other rare kidney diseases, including atypical hemolytic uremic syndrome (aHUS), immune complex membranoproliferative glomerulonephritis (IC-MPGN), and lupus nephritis (LN).

Additionally, zigakibart, an investigational anti-APRIL monoclonal antibody, is in Phase III development for IgAN, with trial results expected in 2026.