Posted by Michael Wonder on 09 Jan 2025
US FDA confirms class 1 resubmission of the supplemental new drug application for Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy
8 January 2025 - Astellas today announced the US FDA accepted the revised supplemental new drug application for Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy secondary to age-related macular degeneration on 6 January 2025, in response to the Agency's November 2024 complete response letter.
The application was refiled following a 20 December 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 26 February 2025.
