FDA delays Regeneron application review after inspection at Novo Nordisk Indiana site

Regeneron Pharmaceuticals, based in Tarrytown, New York, said the U.S. Food and Drug Administration has extended the target action dates to the fourth quarter of 2025 for two Eylea HD (aflibercept) Injection 8 mg submissions. 

These include a Chemistry, Manufacturing and Controls Prior-Approval Supplement for the Eylea HD prefilled syringe and a supplemental Biologics License Application seeking approval for both the treatment of macular edema following retinal vein occlusion and the broadening of the dosing schedule to include every four-week dosing across approved indications.

The FDA extended the review periods after determining that information provided since the completion of a recent inspection of a third-party manufacturer constituted a major amendment to each submission, the company said. The inspection took place at Catalent Indiana LLC, a fill-finish site in Bloomington, Indiana, acquired by Novo Nordisk A/S in December 2024. Novo Nordisk submitted a response in early August to address FDA observations.

STAT obtained a copy of the FDA inspection report and said “hair, pests, bacteria, and equipment failures” were among the concerns cited by the agency.

Pharma Manufacturing previously reported that the FDA issued a Complete Response Letter to Regeneron on July 30 for its odronextamab application, also tied to the Bloomington site inspection. The facility handles the final stages of drug preparation and packaging for both odronextamab and Eylea HD.

Eylea HD remains available in the U.S. through vial administration. It is approved with dosing intervals from every 8 to 16 weeks for patients with wet age-related macular degeneration and diabetic macular edema, and every 8 to 12 weeks for patients with diabetic retinopathy, following three initial monthly doses, said Regeneron.