News
Article
Author(s):
Regeneron Pharmaceuticals announced FDA extended review timelines to Q4 2025 for two regulatory submissions related to Eylea HD due to a major amendment stemming from a third-party manufacturing inspection. Despite the delay, Eylea HD remains available in the U.S., and Regeneron anticipates a swift resolution as they address manufacturing concerns and continue expanding treatment options.
FDA announced it will be pushing the target action dates to the fourth quarter of 2025 for two of the Eylea HD 8mg injection submissions.
Stock.adobe.com
Regeneron Pharmaceuticals announced that FDA granted an extension on target action dates, pushing them until the fourth quarter of 2025 for two Eylea HD (aflibercept) 8mg Injection regulatory submissions. The extension also includes Chemistry Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for Eylea HD prefilled syringe, along with a supplemental Biologics License Application (sBLA) seeking approval for a macular edema treatment following vein occlusion. The extension will also expand the dosage schedule to include monthly dosage spanning all approved indications.
FDA granted the extended review periods due to the information provided from a recent inspection conducted at a third-party manufacturer, constituting a major amendment to each submission. The delays were expected, as discussed during Regeneron’s second quarter 2025 earnings announcement, in result of observations recorded during an FDA general site inspection at Catalent Indiana LLC. Catalent, recently acquired by Novo Nordisk, submitted its response earlier this month directly addressing the observations noted by FDA.
“Novo has been in communication with the FDA and expects to submit its response next week,” Regeneron stated in a press release. “Based on the Company's review of the observations and Novo's proposed response to the FDA, along with the progress the Company has made with alternate third-party fillers, the Company anticipates an expeditious resolution of the filling issues for Eylea HD.”2
Regeneron introduced Eylea, a vascular endothelial growth factor inhibitor, over a decade ago and transformed treatment paradigms for select serious choriretinal vascular diseases. Since its introduction, Eylea has established an efficient and consistent safety portfolio spanning across 16 pivotal trials.
Eylea received approval for treatment of vison-threatening conditions such as retinopathy of prematurity. Additionally, patients can also be impacted during the later years of their lives, as many can be diagnosed with diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion, and wet age-related macular degeneration.
Eylea, and its success as a treatment option for vison-threatening conditions did not keep Regeneron from testing the scientific boundaries to achieve patient needs. Regeneron developed Eylea HD aiming to achieve the same effects as Eylea while also reducing the total amount of injections required into a patients’ eye.
Eylea HD will remain available throughout the U.S. via vial administration and is approved for dosing intervals ranging from every 8 to 16 weeks, in patients with wet age-related macular degeneration and diabetic macular edema. The treatment is also available every 8 to 12 weeks for patients diagnosed with diabetic retinopathy following three initial monthly dosages
Lead with insight with the Pharmaceutical Executive newsletter, featuring strategic analysis, leadership trends, and market intelligence for biopharma decision-makers.
