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FDA accepts revised supplemental New Drug Application for IZERVAY
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Key Takeaways
- The FDA accepted the revised sNDA for IZERVAY, addressing a previous Complete Response Letter from November 2024.
- The resubmission is classified as Class 1, with a 60-day review period, targeting a decision by February 26, 2025.
The application was refiled following a December 20, 2024, meeting between the US Food and Drug Administration and Astellas.
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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 (CRL).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:
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
