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FDA Medication Tracker

← All approvals · Kidney, liver & lung · 2025

Vanrafia (atrasentan)

The FDA approved Vanrafia (atrasentan) on April 2, 2025 to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression.
Brand name
Vanrafia
Generic name
atrasentan
FDA approval date
April 2, 2025
Approved use (FDA wording)
To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression
Company
Novartis
Application
NDA219208
Dosage form / route
TABLET · ORAL
Boxed warning on label
Yes (see the FDA label)
Category on this site
Kidney, liver & lung

Indications and usage, from the FDA label

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 [see Clinical Studies (14.1)] . 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. VANRAFIA is an endothelin receptor antagonist indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy…

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.