FDA Accepts Astellas Pharma's Revised SNDA For IZERVAY In Geographic Atrophy Treatment

(RTTNews) - Astellas Pharma Inc. (ALPMY, ALPMY) announced that the U.S. Food and Drug Administration accepted the revised supplemental New Drug Application or 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 company noted that 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 U.S. Food and Drug Administration on August 4, 2023, for the treatment of geographic atrophy secondary to macular degeneration.

The sNDA seeks to add positive 2-year data to the IZERVAY U.S. Prescribing Information based on results from the GATHER2 Phase 3 clinical trial.

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