FDA Rejects Regeneron's Eylea HD
Regeneron plans to re-apply to the FDA in January 2026 with a new pre-filled syringe manufacturing filler.
The US Food and Drug Administration (FDA) rejected a prefilled syringe version of Regeneron's Eylea HD (aflibercept) due to manufacturing issues.
- The FDA issued a complete response letter for Eylea HD's pre-filled syringe supplemental biologics licence application (sBLA).
- The rejection was caused by unresolved issues at Novo Nordisk's filling plant in Bloomington, Indiana.
The sole reason for the rejection was unresolved issues at a facility of its manufacturing partner, Novo Nordisk.
Author's summary: FDA rejects Eylea HD due to manufacturing issues.
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