Overview
Novartis said Friday that its investigational therapy Vanrafia demonstrated an ability to slow the decline in kidney function among adults diagnosed with IgA nephropathy (IgAN), a progressive autoimmune disorder affecting the kidneys. The announcement was based on phase 3 clinical trial results that the company reported showed improvements in kidney filtration rates for patients with the condition.
Clinical findings
The phase 3 findings cited by Novartis indicate that Vanrafia produced measurable improvements in kidney filtration rates among the trial population. The company framed those results as evidence that the drug can slow the deterioration of renal function in adults with IgAN.
About IgA nephropathy
IgA nephropathy is described by Novartis as a progressive autoimmune disease that causes inflammation in the small filtering units of the kidneys. The inflammation can lead to excess protein in the urine, a condition known as proteinuria, which is a key clinical manifestation of the disease.
Regulatory status and next steps
Vanrafia received accelerated approval in the United States and in China in 2025 specifically for the treatment of proteinuria in adults with IgAN. Following the positive phase 3 results, Novartis said it plans to submit Vanrafia for traditional regulatory approval in 2026.
Implications
The phase 3 data combined with prior accelerated approvals positions Vanrafia for a conventional approval pathway beginning with a submission in 2026. The development sequence highlighted by Novartis shows an accelerated authorization for a symptom-based indication followed by pursuit of a standard approval after confirmatory trial evidence.
Key points
- Phase 3 trials reported by Novartis indicate Vanrafia improved kidney filtration rates in adults with IgAN.
- Vanrafia was granted accelerated approval in 2025 in both the United States and China for treating proteinuria in adults with IgAN.
- Novartis intends to seek traditional regulatory approval for Vanrafia in 2026.
Risks and uncertainties
- The plan to submit for traditional approval in 2026 means the drug will be subject to further regulatory review before receiving full approval - the outcome of that process is not stated in the announcement.
- The accelerated approvals granted in 2025 were specifically for treating proteinuria; the relationship between that authorized indication and the phase 3 finding of slowed kidney function decline is described by the company but the announcement does not provide additional regulatory detail.
Conclusion
Novartis presented phase 3 data indicating Vanrafia can slow kidney function decline in adults with IgAN and noted prior accelerated approvals in the United States and China in 2025 for treatment of proteinuria. The company plans to pursue traditional approval in 2026, initiating a formal regulatory review process for the therapy.