On August 18, 2023, Regeneron Pharmaceuticals, Inc. (“Regeneron”) announced that the FDA approved EYLEA HD®, an 8 mg injection of EYLEA® (aflibercept). EYLEA HD®, jointly developed with Bayer A.G., is approved for the treatment of wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR). EYLEA® was previously approved by the FDA in 2011 as a 2 mg dose, available in a single-dose pre-filled syringe or vial. FDA approval for the higher dose EYLEA HD® comes shortly after the FDA issued a Complete Response Letter (“CRL”) regarding inspection findings at a third-party filler.
On the same day, Regeneron also announced FDA approval of VEOPOZ™ (pozelimab-bbfg) for the treatment of CHAPLE disease, also known as CD55-deficient protein-losing enteropathy. VEOPOZ™ is the first product approved by the FDA for treatment of CHAPLE disease in children and adults. According to Regeneron, CHAPLE disease is a life-threatening, ultra-rare blood disease currently identified in less than 10 patients in the United States, and each single-use vial of VEOPOZ™ will be priced at $34,615.38.