FDA Extends Target Action Dates to Fourth Quarter for Two Eylea HD Submissions
Due to problems identified in a general FDA inspection of its third-party contract manufacturer, the FDA has extended the target action dates to the fourth quarter of 2025 for two Eylea HD (aflibercept injection 8 mg) regulatory submissions. The submissions include a prior-approval supplement (PAS) for the Eylea HD prefilled syringe, and a supplemental Biologics License Application (sBLA) seeking approval for both the treatment of macular edema following retinal vein occlusion (RVO) and the broadening of the dosing schedule to include every 4-week (monthly) dosing across approved indications.
The FDA extended the review periods after determining that information provided since the completion of a recent inspection of a third-party manufacturer constituted a major amendment to each submission.
The delay was anticipated by Regeneron and resulted from observations during an FDA general site inspection at the filler for these regulatory applications, Catalent Indiana LLC, which was acquired by Novo Nordisk A/S in December 2024. Regeneron discussed the issue during its second quarter 2025 earnings announcement.
According to Regeneron, Novo Nordisk submitted a comprehensive response in early August 2025 to address the observations noted by the FDA. "It is our understanding that the FDA will be able to act expeditiously on these applications once the manufacturing issues have been resolved," Regeneron stated in a news release.
Eylea HD remains available in the US through vial administration. It is approved with dosing intervals from every 8 to 16 weeks for patients with wet age-related macular degeneration (AMD) and diabetic macular edema (DME), and every 8 to 12 weeks for patients with diabetic retinopathy (DR), following 3 initial monthly doses.
In June, the European Commission (EC) granted a label extension in the European Union (EU) for Eylea 8 mg with extended treatment intervals of up to 6 months for the treatment of wet AMD and diabetic macular edema (DME). However in April, the FDA issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for the addition of extended dosing intervals (up to every 24 weeks) for Eylea HD (aflibercept) Injection 8 mg across all approved indications. According to Regeneron, the CRL did not identify any issues with the safety or efficacy of Eylea HD in its approved indications and dosing regimens.