Regeneron says FDA delayed review of two Eylea HD submissions

Regeneron (REGN) Pharmaceuticals announced that the Food and Drug Administration has extended the target action dates to Q4 of 2025 for two Eylea HD injection regulatory submissions. This includes 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 4-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 in a statement. The delay was anticipated and resulted from observations during an FDA general site inspection at the filler for these regulatory applications, Catalent Indiana, which was acquired by Novo Nordisk (NVO) n December 2024, it added. “Novo Nordisk submitted a comprehensive response in early August 2025 to address the observations noted by the FDA. It is our understanding that the FDA will be able to act expeditiously on these applications once the manufacturing issues have been resolved,” Regeneron said.