Novartis Secures Third FDA Approval For Its Kidney Disease Portfolio In One Year

The U.S. Food and Drug Administration (FDA) on Wednesday granted accelerated approval for Novartis AG’s NVS Vanrafia (atrasentan) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression.

Vanrafia is a once-daily, non-steroidal, oral treatment that can be added to supportive care, including a renin-angiotensin system inhibitor with or without a sodium-glucose co-transporter-2 inhibitor.

Vanrafia was granted accelerated approval based on a prespecified interim analysis of the Phase 3 ALIGN study measuring the reduction of proteinuria at 36 weeks compared to placebo.

Also Read: FDA Reviews Kidney Disease Drug From Apellis Pharmaceuticals

It has not been established whether Vanrafia slows kidney function decline in patients with IgAN.

The continued approval of Vanrafia may be contingent upon verifying clinical benefit from the ongoing Phase 3 ALIGN study evaluating whether Vanrafia slows disease progression as measured by estimated glomerular filtration rate (eGFR) decline at week 136.

The eGFR data are expected in 2026 and are intended to support traditional FDA approval.

In the ongoing Phase 3 ALIGN study, patients receiving Vanrafia in combination with a RAS inhibitor achieved clinically meaningful and statistically significant proteinuria reduction of 36.1% compared to placebo, with results seen as early as week 6 and sustained through week 36.

A similar treatment effect of Vanrafia was seen in an additional group of patients treated with both an RAS inhibitor and an SGLT2 inhibitor (37.4% reduction in UPCR vs. placebo).

The ALIGN study showed that Vanrafia has a favorable safety profile consistent with previously reported data.

This is Novartis’s third U.S. approval for its kidney disease portfolio in the last year. Fabhalta was granted FDA approval in C3 glomerulopathy in March 2025 and accelerated approval in IgAN in August 2024.

Fabhalta is also being studied in rare kidney diseases, including atypical hemolytic uremic syndrome, immune complex membranoproliferative glomerulonephritis, and lupus nephritis.

An investigational subcutaneously administered anti-APRIL monoclonal antibody, zigakibart, is currently in Phase 3 development in IgAN, with results expected in 2026.

Price Action: NVS stock is up 2.16% at $113.17 at the last check Thursday.

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