Novartis AG (NVS) reported final results from the Phase III ALIGN study showing that Vanrafia slowed kidney function decline over 2.5 years in adults with IgA nephropathy (IgAN). The findings, published in The Lancer and presented at the European Renal Association Congress, demonstrated an approximately 34% reduction in the rate of decline compared to placebo, alongside sustained reductions in proteinuria.
IgAN is a progressive autoimmune kidney disease that leads to inflammation, excess protein in urine, and gradual loss of kidney function. Up to half of patients with persistent proteinuria progress to kidney failure within 10-20 years, often requiring dialysis or transplantation.
In the ALIGN trial, 340 patients with biopsy-proven IgAN were randomized to receive once-daily oral Vanrafia or placebo for approximately 132 weeks, in addition to standard supportive care with renin-angiotensin system (RAS) inhibitor. A subgroup also received SGLT2 inhibitors. Results showed consistent benefits across measures of kidney function, including an annualized eGFR slope of -2.7 with Vanrafia versus -4.1 with placebo, and a 38.3% relative reduction in proteinuria at nine months.
"These results provide robust evidence of clinically meaningful slowing of kidney function decline over more than two years of treatment," said Dr. Richard Lafayette of Stanford University, an ALIGN study investigator. Novartis added that the data reinforce Vanrafia's potential as a foundational therapy for IgAN and will be used to support submissions for traditional approval in 2026.
Safety was consistent with prior studies, with adverse events similar to placebo and no new signals observed. Vanrafia had previously received accelerated approval in the U.S. and China in 2025 for reduction of proteinuria in IgAN.
NVS has traded between $112.34 and $170.46 over the past year. The stock closed Wednesday's trading at $143.66, up 0.13%. In pre-market trading the stock is at $145.37, up 1.18%.
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