Regeneron Receives Another CRL for Eylea 8 mg
Regeneron faces another FDA setback for Eylea HD due to manufacturing issues.
The US Food and Drug Administration (FDA) issued a complete response letter (CRL) for the company’s request for approval of its prefilled syringe option of high-dose (HD) Eylea (aflibercept) 8 mg.
- The FDA cited unresolved issues at the Bloomington, Indiana, plant of Novo Nordisk, Regeneron’s manufacturing partner.
- 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.
Regeneron plans for new facilities signal future production improvements.
Author's summary: Regeneron faces FDA setback for Eylea HD.
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