FDA Rejects Regeneron's Eylea HD
The US Food and Drug Administration (FDA) has rejected a prefilled syringe version of Regeneron's Eylea HD (aflibercept) due to manufacturing issues.
Regeneron announced the setback in its Q3 earnings, stating that the FDA issued a complete response (CR) letter for Eylea HD's pre-filled syringe supplemental biologics licence application (sBLA).
The reason for the rejection was unresolved issues at a facility of its manufacturing partner, Novo Nordisk, in Bloomington, Indiana, which were uncovered by the FDA during an inspection.
The sole reason for the rejection was unresolved issues at a facility of its manufacturing partner, Novo Nordisk.
Regeneron plans to re-apply to the FDA with a new pre-filled syringe manufacturing filler in January 2026.
Author's summary: FDA rejects Regeneron's Eylea HD due to manufacturing issues.
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