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