Vanrafia FDA Approval History
Last updated by Judith Stewart, BPharm on April 4, 2025.
FDA Approved: Yes (First approved April 2, 2025)
Brand name: Vanrafia
Generic name: atrasentan
Dosage form: Tablets
Company: Novartis Pharmaceuticals Corporation
Treatment for: Immunoglobulin A Nephropathy
Vanrafia (atrasentan) is an endothelin A receptor antagonist used for proteinuria reduction in primary immunoglobulin (IgA) nephropathy.
- Vanrafia is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g.
This indication is approved under accelerated approval based on a reduction of proteinuria. It has not been established whether Vanrafia slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial. - IgAN is a rare kidney disease caused by an autoimmune reaction to an abnormal form of immunoglobulin A, resulting in the formation of immune complexes that deposit in the kidneys. The immune complexes cause glomerular inflammation and proteinuria that can lead to progressive kidney damage and loss of kidney function. Endothelin (ET)-1 is thought to contribute to the pathogenesis of IgAN via the endothelin A (ETA) receptor.
- Vanrafia contains atrasentan, an endothelin A receptor antagonist that works by blocking the ETA receptor.
- Vanrafia was granted accelerated approval by the U.S. Food and Drug Administration (FDA) based on a pre-specified interim analysis of the Phase III ALIGN study measuring the reduction of proteinuria at 36 weeks compared to placebo. The continued approval of Vanrafia may be contingent upon the verification of clinical benefit from the ongoing Phase III ALIGN study evaluating whether Vanrafia slows disease progression as measured by estimated glomerular filtration rate (eGFR) decline at week 136. The eGFR data are expected in 2026 and intended to support traditional FDA approval.
- Vanrafia tablets are administered orally once daily with or without food.
- Vanrafia comes with a Boxed Warning for major birth defects if used during pregnancy. Warnings and precautions include hepatotoxicity, fluid retention, and decreased sperm counts.
- Common adverse reactions (incidence ≥ 5%) include peripheral edema and anemia.
Development timeline for Vanrafia
Further information
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