Regeneron's Eylea injection review dates delayed by FDA

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Regeneron Pharmaceuticals (NASDAQ:REGN [https://seekingalpha.com/symbol/REGN]) announced that the U.S. FDA has extended the target action dates for two regulatory submissions related to Eylea HD (aflibercept) injection 8 mg to the fourth quarter of 2025.

This encompasses a prior-approval supplement for the Eylea HD prefilled syringe and a label expansion submission for treating macular edema after retinal vein occlusion, along with a proposal to expand the dosing schedule to every 4 weeks across approved uses.

The medication is approved for dosing intervals ranging from every 8 to 16 weeks for patients with wet age-related macular degeneration and diabetic macular edema.

This extension comes as the FDA reviewed additional information provided following a recent inspection of a third-party manufacturer, Catalent Indiana LLC. The FDA regarded this new information as a major amendment, prompting the extension of its review timelines.

Catalent Indiana LLC was acquired by Novo Nordisk (NVO [https://seekingalpha.com/symbol/NVO]) in December 2024.

Following the inspection, the company said that Novo Nordisk submitted a comprehensive response in early August 2025, aiming to address the FDA's observations and facilitate progress in the regulatory review process.

The company said [https://seekingalpha.com/pr/20206937-eylea-hd-aflibercept-injection-8-mg-applications-for-expanded-u-s-label-and-prefilled-syringe]that Eylea HD remains available in the U.S. through vial administration.

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