FDA Accepts sNDA for Izervay
Astellas Pharma Inc. announced the FDA 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, in response to the Agency's November 2024 Complete Response Letter (CRL).
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.A target action date has been set for February 26, 2025.
Izervay was approved by the FDA on August 4, 2023, for the treatment of GA secondary to AMD. . The sNDA seeks to add positive 2-year data to the Izervay U.S. Prescribing Information based on results from the GATHER2 Phase III clinical trial.
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