Regeneron Expects FDA Decision on High-Dose Aflibercept in Third Quarter

During its second quarter conference call, Regeneron said it anticipates the FDA will take action on its biologics license application (BLA) for high-dose aflibercept during the third quarter.

In June, citing "an ongoing review of inspection findings at a third-party filler," the FDA declined to approve Regeneron's aflibercept 8 mg for the treatment of patients with wet age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy (DR). In a complete response letter (CRL), the FDA did not identify any issues with the aflibercept 8 mg clinical efficacy or safety, trial design, labeling or drug substance manufacturing, and no additional clinical data or trials were requested.

Regeneron said since the CRL, it has been submitting manufacturing data required by the FDA on a rolling basis, and expects to finish the submissions by mid-August.

“The CRL was issued solely due to unresolved observations resulting from an FDA inspection at a third-party contract manufacturing organization, Catalent, that the company engaged to complete vial-filling for aflibercept 8 mg. … The FDA has informed the company and Catalent that certain manufacturing data and other information are required from Catalent to allow the FDA to approve aflibercept 8 mg; the company expects that these data and information will be submitted to the FDA by mid-August 2023. The FDA has stated that it intends to prioritize the review of this submission, and therefore the company anticipates the FDA will take action on the aflibercept 8 mg BLA during the third quarter of 2023,” Regeneron stated in a news release.

Regeneron reported US sales of Eylea (aflibercept 2 mg) of $1.5 billion in the second quarter—about 7 percent lower than sales in the same quarter of 2022—but above estimates of $1.48 billion. Regeneron said the drop was primarily due to a lower net selling price driven by changing market dynamics, including increased competition.