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FDA Agrees to Review Eylea (Aflibercept) for Diabetic Macular Edema
Approval decision expected in August 2014 (December 18)
The FDA has accepted for standard review a supplemental biologics license application (sBLA) for Eylea (aflibercept, Regeneron Pharmaceuticals) injection for the treatment of diabetic macular edema (DME). Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an sBLA is 10 months from submission, for a target action date of August 18, 2014.
Eylea (aflibercept) was approved in the U.S. for the treatment of neovascular (wet) age-related macular degeneration (AMD) in November 2011 and for the treatment of macular edema following central retinal vein occlusion in September 2012.
Vascular endothelial growth factor (VEGF) is a naturally occurring protein in the body. Its normal role in a healthy organism is to trigger the formation of new blood vessels (angiogenesis) supporting the growth of the body’s tissues and organs. However, in certain diseases, such as neovascular AMD, it is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability leading to edema. Scarring and loss of fine-resolution central vision often results.
Aflibercept, known in the scientific literature as VEGF Trap-Eye, is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human immunoglobulin G1 (IgG1) and formulated as an iso-osmotic solution for intravitreal administration. Aflibercept acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF), thereby inhibiting the binding and activation of their cognate VEGF receptors.
Source: Regeneron; December 18, 2013.