FDA Issues Complete Response Letter to Astellas for IZERVAY Supplemental New Drug Application
FDA Decision:
The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Astellas Pharma Inc. for the supplemental New Drug Application (sNDA) of IZERVAY (avacincaptad pegol intravitreal solution), a treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD)245.
Reason for Rejection:
The FDA's rejection is not related to the safety, efficacy, or risk of use for IZERVAY but rather to a statistical matter concerning proposed labeling language for the product245.
Background:
IZERVAY was approved by the FDA on August 4, 2023, for the treatment of GA secondary to AMD. The sNDA aimed to include positive 2-year data from the GATHER2 Phase 3 clinical trial in the U.S. Prescribing Information12.
Astellas Response:
Astellas plans to seek further clarification from the FDA and work with the agency to address the feedback. The company stands by the clinical profile of IZERVAY and remains committed to advancing solutions for patients with GA245.
Clinical Trial:
The GATHER2 Phase 3 clinical trial evaluated the safety and efficacy of monthly and every other month dosing of IZERVAY through year 21.
Sources:
1. https://www.astellas.com/en/news/29016
2. https://www.ophthalmologytimes.com/view/fda-issues-crl-to-astellas-supplemental-new-drug-application-for-avacincaptad-pegol-intravitreal-solution-izervay-
4. https://www.modernretina.com/view/us-fda-issues-complete-response-letter-crl-avacincaptad-pegol-intravitreal-solution-izervay-
5. https://europe.ophthalmologytimes.com/view/us-fda-issues-complete-response-letter-for-avacincaptad-pegol-izervay-astellas-pharma-inc-