Novartis’ Vanrafia Shows Strong Phase 3 Results in IgA Nephropathy, Paving Way for Full Approval

Novartis announced that its investigational drug Vanrafia has successfully demonstrated the ability to slow kidney function decline in adults living with IgA nephropathy (IgAN), a chronic and progressive autoimmune kidney disease. The positive results from a phase 3 clinical trial mark a significant development for patients affected by this serious condition, which can ultimately lead to kidney failure.

IgA nephropathy occurs when immunoglobulin A (IgA) deposits build up in the small filtering units of the kidneys, triggering inflammation and long-term damage. Over time, this inflammation reduces the kidneys’ ability to filter waste from the blood effectively. A common symptom of IgAN is proteinuria, or excess protein in the urine, which is a key indicator of kidney damage and disease progression.

According to Novartis, patients treated with Vanrafia in the late-stage trial experienced improved kidney filtration rates compared to those who did not receive the therapy. By slowing the decline in kidney function, Vanrafia may help delay the progression of IgA nephropathy and reduce the risk of advanced kidney disease. These findings reinforce earlier data supporting the drug’s potential as a targeted treatment option for adults diagnosed with IgAN.

Vanrafia previously received accelerated approval in the United States and China in 2025 for the treatment of proteinuria in adults with IgA nephropathy. Accelerated approval allows promising therapies to reach patients sooner based on surrogate endpoints, such as reductions in proteinuria, while confirmatory trials are completed.

Following the encouraging phase 3 results, Novartis plans to submit Vanrafia for traditional regulatory approval in 2026. If granted, full approval would solidify Vanrafia’s role as a new treatment option in the growing IgA nephropathy market, offering hope to patients seeking effective therapies to manage this progressive kidney disease.