Novartis Says Conditionally Approved Kidney Drug Shows Long-Term Promise
On Friday, Novartis AG (NYSE:NVS) shared final results from the Phase 3 ALIGN study supporting a slowing decline in kidney function in adults with IgA nephropathy (IgAN) who were treated with Vanrafia (atrasentan).
IgAN (Berger's disease) is a chronic autoimmune kidney disease caused by the buildup of immunoglobulin A (IgA) protein in the glomeruli, causing inflammation and reducing the kidneys’ ability to filter waste.
Vanrafia received accelerated approval in the U.S. and China for the reduction of proteinuria in adults with IgAN in April 2025. After the trial data, Novartis plans to submit for traditional approval in 2026.
In April 2025, the company said it had not been established whether Vanrafia slows kidney function decline in patients with IgAN.
The continued approval of Vanrafia was 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.
Novartis Vanrafia Phase III Data Support Slowing Of Kidney Function Decline
On Friday, Vanrafia showed a difference of 2.39 ml/min/1.73m2 in estimated glomerular filtration rate (eGFR) change from baseline vs. placebo (2-sided p = 0.057) at Week 136, 4 weeks after the end of study treatment.
Clinically meaningful results were observed with Vanrafia compared to placebo in eGFR change from baseline at the end of study treatment at Week 132, and in the prespecified exploratory group of patients additionally receiving sodium-glucose co-transporter-2 (SGLT2) inhibitors.
At the end of treatment at Week 132, the eGFR change from baseline compared to placebo was 2.59 ml/min/1.73 m2.
The company on Friday said that ALIGN provides the longest follow-up period in pivotal Phase 3 studies for IgAN. Safety was consistent with previous findings.
Alongside Vanrafia, Novartis continues to advance its multi-asset IgAN portfolio, which also includes Fabhalta (iptacopan) and investigational compound zigakibart.
NVS Price Action: Novartis shares were up 0.42% at $161.86 during premarket trading on Friday. The stock is trading near its 52-week high of $162.31.
Photo via Shutterstock
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