Novartis Reports Positive Data From Phase III ALIGN Study For Vanrafia In IgA Nephropathy
(RTTNews) - Novartis (NVS) announced that final results from a phase 3 trial of Vanrafia support slowing of kidney function decline in patients with IgA nephropathy.
Vanrafia was granted accelerated approval by the FDA last April for proteinuria reduction in primary IgA nephropathy. The drug has also been granted accelerated approval in China for the same indication.
IgAN is a progressive autoimmune kidney disease with approximately 25 per million people newly diagnosed worldwide each year, according to Novartis. IgAN leads to inflammation of the small filters in the kidneys, proteinuria or excess protein in urine and a gradual decline in estimated glomerular filtration rate (eGFR).
In the phase 3 trial, dubbed ALIGN, Vanrafia showed clinically meaningful improvements in eGFR compared to placebo at Week 132, including in patients also taking SGLT2 inhibitors, with a 2.59?mL/min/1.73?m² higher eGFR at the end of the study.
At Week 136, i.e. four weeks after the end of treatment, Vanrafia demonstrated a positive effect on kidney function, showing a 2.39?mL/min/1.73?m² improvement in eGFR compared to placebo.
"We are pleased with today's Phase III ALIGN results, which add to the growing evidence of Vanrafia as a potential foundational therapy to slow kidney function decline," said Ruchira Glaser, Global Head, Cardiovascular, Renal & Metabolic Development Unit, Novartis.
Novartis plans to seek traditional approval for Vanrafia this year.
Recently, Novartis released fourth-quarter and full-year 2025 financial results.
The company's core net income was $17.41 billion, or $8.98 per share, in full-year 2025, compared with $15.76 billion, or $7.81 per share, in 2024.
Net sales for 2025 climbed 8% to $54.53 billion from $50.32 billion in the prior year.
NVS closed Thursday's trade at $161.18, up 0.70%. In the overnight market, NVS is down 0.02%, at $161.15.
