Treats geographic atrophy (GA) secondary. NDA 217225, held by Astellas. Avacincaptad Pegol Sodium.
As of Nov 13, 2026, NDA 217225 (Izervay), held by Astellas, was first approved by FDA on Aug 4, 2023, with 2 approved supplements and 0 published complete response letters.
IZERVAY is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
| Feb 12, 2025 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Aug 4, 2023 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| IzervayEQ 2MG BASE/0.1ML (EQ 2MG BASE/0.1ML) · solution;intravitreal | Avacincaptad Pegol Sodium | RxReference drug |
| Feb 27, 2026 | Supplement 4Labeling · Standard review | Approved | |
| Feb 12, 2025 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Aug 4, 2023 | Original applicationNew molecular entity · Priority 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
