Approval Letter Other 217225 (Nov 13, 2025)

Summary

This is a Complete Response letter from the FDA to Astellas Pharma US, Inc. regarding their supplemental New Drug Application (sNDA) for IZERVAY (avacincaptad pegol intravitreal solution). The FDA has determined that the application cannot be approved in its present form due to insufficient data supporting an expanded dosing regimen and outlines deficiencies and recommendations for resubmission.

Key points

• Submit data from adequate and well-controlled studies demonstrating the efficacy of Izervay with an extended dosing regimen to support proposed labeling revisions.
• Review labeling review resources, including regulations, guidance documents, and the Selected Requirements for Prescribing Information (SRPI) checklist, if revising labeling.
• Ensure Prescribing Information conforms with format items in regulations and guidances using the SRPI checklist if labeling is revised.
• Include updated content of labeling in structured product labeling (SPL) format as described at FDA.gov if labeling is revised.
• Include a safety update as described at 21 CFR 314.50(d)(5)(vi)(b) when responding to deficiencies.
• Describe in detail any significant changes or findings in the safety profile in the safety update.
• Present new safety data from studies/clinical trials for the proposed indication using the same format as in the original submission.
• Present tabulations of new safety data combined with the supplemental application data.

Cited reasons

• Insufficient Efficacy Data for Extended Dosing Regimen
• Comprehensive Safety Update Required
• Labeling Comments Reserved Pending Efficacy Resolution
• The FDA issued a Complete Response Letter for the sNDA proposing an extended dosing regimen for IZERVAY. The primary reason for non-approval is the lack of sufficient efficacy data from adequate and well-controlled studies to support the extended dosing interval. Additionally, a comprehensive safety update is required upon resubmission, and labeling comments are reserved until the efficacy issues are resolved.

Recommended actions

• Submit data from adequate and well-controlled studies demonstrating the efficacy of Izervay with an extended dosing regimen to support proposed labeling revisions.
• Review labeling review resources, including regulations, guidance documents, and the Selected Requirements for Prescribing Information (SRPI) checklist, if revising labeling.
• Ensure Prescribing Information conforms with format items in regulations and guidances using the SRPI checklist if labeling is revised.
• Include updated content of labeling in structured product labeling (SPL) format as described at FDA.gov if labeling is revised.
• Include a safety update as described at 21 CFR 314.50(d)(5)(vi)(b) when responding to deficiencies.
• Describe in detail any significant changes or findings in the safety profile in the safety update.
• Present new safety data from studies/clinical trials for the proposed indication using the same format as in the original submission.
• Present tabulations of new safety data combined with the supplemental application data.

Deficiency summary

The FDA issued a Complete Response Letter for the sNDA proposing an extended dosing regimen for IZERVAY. The primary reason for non-approval is the lack of sufficient efficacy data from adequate and well-controlled studies to support the extended dosing interval. Additionally, a comprehensive safety update is required upon resubmission, and labeling comments are reserved until the efficacy issues are resolved.

Findings

Regulatory context

Submission stage

final decision

Regulatory pathway

505(b) sNDA

Impact

Impact score

0.75

Estimated delay

730 days

Estimated rework cost

$0

Subsequent action

resubmission

Strategic insights

The application for an extended dosing regimen of IZERVAY was not approved due to a lack of robust clinical evidence supporting efficacy and incomplete safety data updates. New clinical studies are required to demonstrate efficacy, and a thorough safety data compilation is needed for resubmission.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 25%