Regeneron Received FDA Complete Response Letter For Its Higher Dose Aflibercept Injection BLA

Last week, Regeneron published a press release stating that the FDA had issued a Complete Response Letter (“CRL”) for its aflibercept 8 mg BLA for the treatment of patients with wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy, “due to an ongoing review of inspection findings at a third-party filler,” which has now been announced as Catalent’s Bloomington site in Indiana.  Regeneron added that “[t]he 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’s EYLEA is currently approved by the FDA as a 2 mg dose (0.05 ml), available in a single-dose pre-filled syringe or vial.  Regeneron is jointly developing its higher dose aflibercept with Bayer A.G.  According to the press release, Regeneron is maintaining exclusive rights to aflibercept 8 mg and its other aflibercept injection product EYLEA, in the U.S., while Bayer has “licensed the exclusive marketing rights outside of the U.S., [and] the companies share equally the profits from sales of EYLEA and future sales of aflibercept 8 mg following any regulatory approvals.”