Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s Biologics License Application (BLA) for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD). The FDA also granted the Company’s request for priority review of its BLA. A Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. Under priority review, the target date for an FDA decision on the VEGF Trap-Eye BLA is August 20, 2011.
“We are very pleased that the FDA has chosen to grant priority review to VEGF Trap-Eye. We look forward to working closely with the FDA to achieve our goal of bringing a new treatment option that offers a major advance to patients with age-related macular degeneration,” said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron.
About VEGF Trap-Eye
Vascular 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 diabetes, it is also associated with the growth of abnormal new blood vessels in the eye, which exhibit vascular permeability and lead to edema. VEGF Trap-Eye is a fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1. VEGF Trap-Eye binds all forms of VEGF-A, along with the related Placental Growth Factor (PlGF). VEGF Trap-Eye is a specific and highly potent blocker of these growth factors. VEGF Trap-Eye is specially purified and contains iso-osmotic buffer concentrations, allowing for injection into the eye.
Regeneron and Bayer HealthCare are collaborating on the development of VEGF Trap-Eye for the treatment of wet AMD, central retinal vein occlusion, diabetic macular edema, myopic choroidal neovascularisation, and other eye diseases and disorders. Bayer HealthCare intends to submit a regulatory application outside of the United States in the first half of 2011. If approved by regulatory authorities, Bayer HealthCare will market VEGF Trap-Eye outside the United States, where the companies will share equally in profits from any future sales of VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States.
Source: Regeneron Pharmaceuticals, Inc