US FDA delays decision on Regeneron's wet AMD drug Eylea

US biotech firm Regeneron Pharmaceuticals. (Nasdaq: REGN) says that it has received notification from the Food and Drug Administration that the agency has extended its target date to complete the priority review of the Eylea (aflibercept injection) for intravitreal use, Biologics License Application 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.

The news is something of a surprise, given that the FDA’s the Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously to recommend that the agency approves aflibercept, also known as VEGF Trap-Eye (The Pharma Letter June 20). Regeneron’s shares fell $4.27 to $53.15 in aftermarket trading following the announcement of the FDA delay.