Reduces proteinuria. NDA 219208, held by Novartis. Atrasentan Hydrochloride.
As of Nov 14, 2026, NDA 219208 (Vanrafia), held by Novartis, was first approved by FDA on Apr 2, 2025, with 1 approved supplement and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 2, 2025 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| VanrafiaEQ 0.75MG BASE · tablet;oral | Atrasentan Hydrochloride | RxReference drug |
| Oct 20, 2025 | Supplement 1Labeling · Standard review | Approved | |
| Apr 2, 2025 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
