Regeneron Pharmaceuticals faced a setback as the U.S. Food and Drug Administration (FDA) rejected its application for a prefilled syringe version of Eylea HD, the company’s high-dose formulation of the widely used VEGF inhibitor aflibercept. The rejection centers on ongoing manufacturing compliance issues discovered during a recent FDA inspection at the Bloomington, Indiana manufacturing facility, now operated by Novo Nordisk following its acquisition of Catalent’s site.
The FDA classified the manufacturing site as being in an “unacceptable state of compliance,” citing procedural and process-related deficiencies. Although there were no demands for major structural overhauls, regulators raised serious concerns that delayed FDA decisions on Eylea HD’s expanded label submissions. These submissions included approval for treatment of macular edema following retinal vein occlusion and an adjusted dosing schedule to extend every-4-week administration across indications.
Regeneron’s CEO Leonard Schleifer expressed optimism that the facility’s compliance issues could be resolved quickly, emphasizing the company’s commitment to meeting FDA standards. Novo Nordisk has submitted a comprehensive response to the agency, aiming to address the FDA’s observations comprehensively.
Eylea HD is positioned as a successor to Regeneron’s initial Eylea drug, which has experienced declining sales due to competitive pressure. The high-dose version showed significant sales growth this year, and Regeneron had aimed to strengthen its position in the ophthalmology market with regulatory approvals for new dosing options and formats.
The regulatory hiccup delays Regeneron’s efforts to expand Eylea HD’s clinical use and maintain its competitive edge amid increasing market competition, particularly from Roche’s rival therapies. The company continues to work closely with the FDA and the manufacturing site to resolve outstanding compliance issues swiftly.
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