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Regeneron Announces Review of Biologics License Application for EYLEA™ (aflibercept injection) Extended by Three Months by FDA
Date:8/16/2011

TARRYTOWN, N.Y., Aug. 16, 2011 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the agency has extended its target date to complete the priority review of the EYLEA Biologics License Application (BLA) for the treatment of neovascular age-related macular degeneration (wet AMD) to November 18, 2011, which is a three month extension from the original Prescription Drug User Fee Act (PDUFA) action date.  

The extension is a result of the agency classifying recent responses to questions regarding the chemistry, manufacturing, and controls (CMC) section of the BLA as a major amendment to the BLA.  The new action date will give the agency additional time to review the information submitted.

About EYLEAVascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body.  Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body's tissues and organs.  However, in certain diseases, such as age-related macular degeneration, it is also associated with the growth of abnormal new blood vessels in the eye, which exhibit vascular permeability and lead to edema.  

EYLEA (aflibercept injection) for intravitreal use, also known as VEGF Trap-Eye, is a fully human fusion protein, consisting of portions of VEGF receptors 1 and 2, that binds all forms of VEGF-A along with the related Placental Growth Factor (PlGF).  EYLEA is a specific and highly potent blocker of these growth factors.  EYLEA is specially purified and contains iso-osmotic buffer concentrations, allowing for injection into the eye.

Regeneron and Bayer HealthCare are collaborating on the global development of EYLEA for the treatment of neovascular age-related macular de
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SOURCE Regeneron Pharmaceuticals, Inc.
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