FDA Fast-Tracks Astellas Pharma's IZERVAY Eye Treatment Update with 60-Day Review

U.S. FDA Confirms Class 1 Resubmission of the Supplemental New Drug Application for IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy

TOKYO, Jan. 8, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the U.S. Food and Drug Administration (FDA) accepted the revised supplemental New Drug Application (sNDA) for IZERVAY™ (avacincaptad pegol intravitreal solution)…

FDA accepts revised supplemental New Drug Application for Izervay

The application was refiled following a December 20, 2024, meeting between the US Food and Drug Administration (FDA) and Astellas.

FDA Accepts Revised Avacincaptad Pegol sNDA for Geographic Atrophy

After accepting the avacincaptad pegol sNDA on January 6, 2025, the FDA has set a target action date for February 26.

FDA Fast-Tracks Astellas Pharma's IZERVAY Eye Treatment Update with 60-Day Review

FDA accepts Astellas Pharma's revised sNDA for IZERVAY, featuring positive 2-year trial data for geographic atrophy treatment, with decision expected by Feb 26.