Novartis Vanrafia Phase III data supports slowing of kidney function decline

Novartis (NVS) announced final results from the Phase III ALIGN study supporting a slowing decline in kidney function in adults with IgA nephropathy who were treated with Vanrafia. Vanrafia showed a difference of 2.39 ml/min/1.73m2 in estimated glomerular filtration rate change from baseline vs. placebo 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 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. Vanrafia received accelerated approval in U.S. and China for reduction of proteinuria in adults with IgAN in 2025; Novartis plans to submit for traditional approval in 2026.