FDA Rejects Regeneron's Eylea HD Due to Manufacturing Issues
Regeneron's pre-filled syringe version of Eylea HD (aflibercept) has been rejected by the US Food and Drug Administration (FDA) due to unresolved manufacturing issues.
The rejection was announced in Regeneron's Q3 earnings report, stating that the FDA issued a complete response (CR) letter for Eylea HD's pre-filled syringe supplemental biologics licence application (sBLA).
- The sole reason for the rejection was unresolved issues at a facility of Novo Nordisk, Regeneron's manufacturing partner.
- The FDA uncovered problems during an inspection of Novo Nordisk's filling plant in Bloomington, Indiana, which was reported by Regeneron in August 2025.
Regeneron is planning to re-apply to the FDA with a new pre-filled syringe manufacturing filler in January 2026.
Author's summary: FDA rejects Regeneron's Eylea HD due to manufacturing issues.
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