FDA Rejects Regeneron's Eylea HD Due to Manufacturing Issues, New Filing Planned

The FDA has issued a complete response letter (CRL) to Regeneron, rejecting the supplemental Biologics License Application (sBLA) for the pre-filled syringe version of its high-dose Eylea (aflibercept injection) due to unresolved manufacturing issues at Novo Nordisk's Indiana facility, which acquired the plant from Catalent in late 2024. This manufacturing site received an official action indicated (OAI) letter, the most severe FDA inspection classification, reflecting significant compliance problems that delayed the approval decision. In response, Regeneron plans to submit a new application for an alternate pre-filled syringe manufacturing partner in January 2026, triggering a four-month FDA review, with expectations of a favorable outcome since no other review issues remain. Additionally, Regeneron is pursuing approvals for other Eylea HD indications and dosing schedules, including retinal vein occlusion (RVO) treatment, with FDA target action dates in late November and December. Analysts and investors view the shift to a new manufacturing facility positively, anticipating a resolution to the ongoing production challenges that have hindered Eylea HD's expansion since 2023. Regeneron's CEO expressed optimism about overcoming these regulatory hurdles and advancing the drug's approvals in the near term.