Novartis AG has announced final results from the Phase III ALIGN study evaluating Vanrafia® (atrasentan) in adults with IgA nephropathy (IgAN). The study demonstrated that Vanrafia slowed the decline in kidney function compared to placebo, with a difference of 2.39 ml/min/1.73m2 in estimated glomerular filtration rate (eGFR) change from baseline versus placebo at Week 136, four weeks after the end of treatment (2-sided p = 0.057). Clinically meaningful results were also observed at the end of treatment at Week 132, with an eGFR change from baseline compared to placebo of 2.59 ml/min/1.73 m2 (nominal 2-sided p = 0.039). The safety profile was consistent with previous findings. These results have already been presented. Vanrafia has received accelerated approval in the U.S. and China for the reduction of proteinuria in adults with IgAN in 2025, and Novartis plans to submit for traditional approval in 2026.

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