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 prefilled syringe option of high-dose (HD) Eylea (aflibercept) 8 mg, citing unresolved issues at Novo Nordisk's Bloomington, Indiana, plant.
- The FDA cited manufacturing issues as the reason for the CRL.
- Regeneron's manufacturing partner, Novo Nordisk, had quality control lapses, including a "pest" found on the manufacturing line in November 2024.
- The FDA tagged Novo's Indiana facility with an official action indicated (OAI) label.
The FDA rejected a new blood cancer therapy due to problems at this same Novo Nordisk-owned site in August 2025.
Regeneron plans for new facilities signal future production improvements.
Author's summary: Regeneron faces FDA setback for Eylea HD due manufacturing issues.
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