FDA Approves Extended Dosing for Astellas’ Izervay, Intensifying Competition in Geographic Atrophy Treatment
The FDA approved an expanded label for Astellas' Izervay (avacincaptad pegol intravitreal solution) for treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD)123.
The new label allows for flexible dosing without limitations on duration, providing greater options for patients and healthcare providers in managing GA123.
Approval follows Astellas' resubmission of a supplemental New Drug Application (sNDA) on December 26, 2024, after receiving a Complete Response Letter from the FDA in November 202423.
The label update is based on positive results from the GATHER2 Phase 3 clinical trial, which evaluated Izervay's efficacy and safety through year 236.
Izervay has shown significant slowing of GA across two pivotal studies and remains the only FDA-approved treatment to do so23.
Since its launch in 2023, over 210,000 vials of Izervay have been distributed in the U.S. as of December 202426.
Izervay's main competitor is Apellis' Syfovre, which was approved earlier and has shown strong sales despite safety concerns47.
The expanded label for Izervay is expected to intensify the market competition between Astellas and Apellis in the GA treatment space47.
Sources:
1. https://pharmaphorum.com/news/fda-changes-its-mind-astellas-geographic-atrophy-drug
2. https://www.ophthalmologytimes.com/view/fda-approves-amended-label-for-izervay-for-geographic-atrophy
3. https://eyewire.news/news/fda-expands-label-for-izervay-for-ga-allowing-for-no-limitation-on-duration-of-dosing
4. https://www.labiotech.eu/in-depth/geographic-atrophy-treatment-apellis-syfovre-astellas-izervay/
6. https://www.stocktitan.net/news/ALPMY/u-s-fda-approves-expanded-label-for-astellas-izervaytm-avacincaptad-whkak6bpxzpl.html
7. https://www.williamblair.com/News/Apellis-Pharmaceuticals-Inc-Initiation