FDA Delays Decisions on Regeneron’s Eylea HD Due to Manufacturing Issues

The FDA has delayed its decisions on two regulatory applications for Regeneron’s Eylea HD (aflibercept), pushing the target action dates to Q4 2025154.

The delays are caused by manufacturing issues at a Novo Nordisk-owned facility in Bloomington, Indiana, which Regeneron uses for filling Eylea vials13.

Regeneron seeks FDA approval for a prefilled syringe version of Eylea HD and a new indication for treating macular oedema following retinal vein occlusion, as well as expanded dosing options1.

The delay was anticipated by Regeneron and disclosed during its Q2 2025 earnings call, after earlier reports of similar manufacturing issues affecting other pipeline drugs13.

Despite these setbacks, Regeneron expects a favorable FDA decision once manufacturing concerns are resolved3.

Eylea HD faces increasing competition from Roche’s Vabysmo as well as newly approved biosimilars, impacting its market share3.

Regeneron's Eylea franchise reported a 25% year-on-year sales decline in Q2 2025, though revenues were still ahead of market expectations3.

Sources:

1. https://www.pharmaceutical-technology.com/news/novos-facility-issues-delay-fda-decisions-on-regenerons-eylea-hd/

3. https://www.biospace.com/fda/two-fda-decisions-for-regenerons-eylea-hd-delayed-into-q4

4. https://www.fiercepharma.com/manufacturing/fda-delays-two-decisions-regenerons-eylea-hd-because-manufacturing-issues

5. https://www.tipranks.com/news/the-fly/regeneron-says-fda-delayed-review-of-two-eylea-hd-submissions-thefly