Astellas Pharma Inc. announced the FDA issued a Complete Response Letter (CRL) on Nov.r 15, 2024, regarding the supplemental New Drug Application (sNDA) for IZERVAY (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The sNDA sought to include positive two-year data in the U.S. Prescribing Information for IZERVAY based on results from the GATHER2 phase 3 clinical trial, which evaluated the efficacy and safety of monthly (EM) and every other month (EOM) dosing through year 2.
The FDA stated the agency cannot approve the sNDA in its present form by the Prescription Drug User Fee Act (PDUFA) action date of Nov. 19, 2024. The FDA comments outlined in the CRL are unrelated to the safety and benefit/risk of the use of IZERVAY; rather, the comments focus on a statistical matter related to labelling language proposed by Astellas.
Astellas is seeking further clarification from the FDA and looks forward to working with the agency to quickly address the agency’s feedback.
Marci English, senior vice president, Biopharma and Ophthalmology Development, Astellas Pharma
“Astellas stands by the clinical profile of IZERVAY, the only FDA-approved GA treatment that consistently demonstrated statistically significant slowing of GA across two pivotal phase 3 studies. While this is a disappointment for patients and physicians who rely on IZERVAY for the management of a chronic, progressive disease that can lead to irreversible vision loss, Astellas is unwavering in our commitment to the ophthalmology space and will continue to work with the FDA to advance solutions for those suffering from GA.”
IZERVAY was approved by the U.S. FDA on Aug. 4, 2023, for the treatment of GA secondary to AMD.
Astellas is reviewing potential financial impacts of this matter for the fiscal year ending March 31, 2025.