FDA accepts Regeneron's VEGF Trap-Eye BLA for review

Apr 18 2011

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.