The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the supplemental new drug application (sNDA) of Astellas Pharma’s IZERVAY (avacincaptad pegol intravitreal solution), a treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
The FDA’s feedback is unrelated to IZERVAY’s safety or efficacy and centres on statistical aspects concerning the proposed labelling language.
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Astellas is seeking further FDA clarification and will resolve the regulator’s concerns promptly.
The application aimed to update the US prescribing information for IZERVAY with positive two-year outcomes from the Phase III GATHER2 trial. This trial investigated the efficacy and safety of IZERVAY with monthly and alternate monthly dosing over two years.
However, the FDA has indicated that it cannot approve the application in its current state by the Prescription Drug User Fee Act (PDUFA) action date set on 19 November 2024.
In August 2023, the US FDA approved IZERVAY for GA secondary to AMD.
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By GlobalDataThe drug met its primary endpoint in the two Phase III, double-masked, sham-controlled, multicentre, and randomised GATHER1 and GATHER2 trials. These involved more than 700 subjects and were designed to evaluate the efficacy and safety of a monthly 2mg intravitreal administration of IZERVAY.
In the first 12 months of the trials, 286 individuals in GATHER1 and 448 in GATHER2 were randomised to receive either IZERVAY 2mg or a sham treatment monthly.
The primary efficacy endpoints were measured by fundus autofluorescence at baseline, month six, and month 12, with safety evaluated across both pivotal studies.
Astellas Pharma biopharma and ophthalmology development senior vice-president Marci English stated: “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 III 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.”
