FDA accepts revised supplemental New Drug Application for Izervay

The US Food and Drug Administration (FDA) has accepted the revised supplemental New Drug Application (sNDA) for Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on January 6, 2025. This revision was in response to the Agency's November 2024 Complete Response Letter.¹

According to the company’s press release¹, the application was refiled following a December 20, 2024, meeting between the FDA and Astellas and has been designated as a Class 1 resubmission, with a 60-day review period. This sets the target action date for February 26, 2025.

The sNDA seeks to add positive 2-year data to the Izervay US Prescribing Information based on results from the GATHER2 Phase 3 clinical trial.¹

The company noted¹ that the impact of this matter on Astellas' financial results for the fiscal year ending March 31, 2025, is expected to be minor.

Izervay was approved by the FDA on August 4, 2023, for the treatment of GA secondary to AMD.¹

Reference:

1. U.S. FDA Confirms Class 1 Resubmission of the Supplemental New Drug Application for IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy. Astellas Pharma Inc. January 8, 2025. Accessed January 10, 2025. https://www.prnewswire.com/news-releases/us-fda-confirms-class-1-resubmission-of-the-supplemental-new-drug-application-for-izervay-avacincaptad-pegol-intravitreal-solution-for-geographic-atrophy-302346418.html