Regeneron Faces FDA Setback for Eylea 8 mg
Regeneron has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for its prefilled syringe option of high-dose (HD) Eylea (aflibercept) 8 mg due to manufacturing issues.
The FDA cited unresolved issues at the Bloomington, Indiana, plant of Novo Nordisk, Regeneron’s manufacturing partner, as the reason for issuing the latest CRL.
- In August 2025, Regeneron announced the FDA rejected a new blood cancer therapy due to problems at this same Novo Nordisk-owned site.
- Quality control lapses were found in November 2024, including a "pest" on the manufacturing line.
- The FDA tagged Novo’s Indiana facility with an official action indicated (OAI) label.
The FDA cited unresolved issues at the Bloomington, Indiana, plant of Novo Nordisk.
Regeneron plans for new facilities signal future production improvements.
Author's summary: Regeneron faces FDA setback for Eylea 8 mg due to manufacturing issues.
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