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 the Bloomington, Indiana, plant of Novo Nordisk, Regeneron’s manufacturing partner.
- In August 2025, the FDA rejected a new blood cancer therapy due to problems at the 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.
No official statement from Regeneron regarding the future plans for Eylea HD.
Regeneron plans for new facilities signal future production improvements.
Author's summary: Regeneron faces FDA setback for Eylea HD due manufacturing issues.