Treats Alexander disease. NDA 220210, held by Ionis Pharms Inc. Zilganersen Sodium.
As of Nov 14, 2026, NDA 220210 (Zanvastro), held by Ionis Pharms Inc, was first approved by FDA on Sep 3, 2026, with 0 approved supplements and 0 published complete response letters.
ZANVASTRO is indicated for the treatment of Alexander disease in pediatric and adult patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 3, 2026 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ZanvastroEQ 56MG BASE/2.8ML (EQ 20MG BASE/ML) · solution;intrathecal | Zilganersen Sodium | RxReference drug |
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
