FDA Rejects Regeneron's Eylea HD
The US Food and Drug Administration (FDA) has rejected a prefilled syringe version of Regeneron's Eylea HD (aflibercept) due to manufacturing shortcomings.
Regeneron announced the setback in its Q3 earnings, stating that the FDA issued a complete response letter for Eylea HD's pre-filled syringe supplemental biologics licence application (sBLA).
The reason for the rejection was unresolved issues at a facility of its manufacturing partner, Novo Nordisk, specifically at their filling plant in Bloomington, Indiana.
The FDA uncovered problems during an inspection of Novo Nordisk's filling plant.
Regeneron plans to re-apply to the FDA with a new pre-filled syringe manufacturing filler in January 2026.
Author's summary: FDA rejects Eylea HD due to manufacturing issues.
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