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Izervay FDA Approval History

Last updated by Judith Stewart, BPharm on Feb 18, 2025.

FDA Approved: Yes (First approved August 4, 2023)
Brand name: Izervay
Generic name: avacincaptad pegol
Dosage form: Intravitreal Solution
Company: Astellas Pharma US, Inc.
Treatment for: Geographic Atrophy

Izervay (avacincaptad pegol) is a complement C5 protein inhibitor indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Development timeline for Izervay

DateArticle
Feb 12, 2025Approval U.S. FDA Approves Expanded Label for Astellas' Izervay (avacincaptad pegol intravitreal solution) for Geographic Atrophy
Aug  5, 2023Approval FDA Approves Izervay (avacincaptad pegol) Intravitreal Solution for the Treatment for Geographic Atrophy
Dec 20, 2022Iveric Bio Announces Completion of Rolling NDA Submission to FDA for Avacincaptad Pegol for the Treatment of Geographic Atrophy
Nov 17, 2022Iveric Bio Announces FDA Has Granted Breakthrough Therapy Designation for Avacincaptad Pegol for Geographic Atrophy
Nov  3, 2022Iveric Bio Announces Submission of First Part of NDA for Rolling Review of Avacincaptad Pegol for the Treatment of Geographic Atrophy
Sep  6, 2022Iveric Bio Announces Positive Topline Data from Zimura® GATHER2 Phase 3 Clinical Trial in Geographic Atrophy

Further information

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