Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for aflibercept 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR), solely due to an ongoing review of inspection findings at a third-party filler.
The CRL 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 have been requested.
Regeneron is committed to working closely with the FDA and the third-party filler to bring aflibercept 8 mg to patients with wAMD, DME and DR as quickly as possible.
Aflibercept 8 mg is being jointly developed by Regeneron and Bayer AG. In the U.S., Regeneron maintains exclusive rights to EYLEA® (aflibercept) Injection and aflibercept 8 mg. Bayer has licensed the exclusive marketing rights outside of the U.S., where the companies share equally the profits from sales of EYLEA and future sales of aflibercept 8 mg following any regulatory approvals.
Aflibercept 8 mg is investigational, and its safety and efficacy have not been approved by any regulatory authority. Regulatory filings for aflibercept 8 mg are under review in Europe and Japan. Submissions to other regulatory authorities in additional countries are also planned.