Regeneron Pharmaceuticals Inc. (REGN) announced that it has received notification from the U.S. Food and Drug Administration that the agency has extended its target date to complete the priority review of the EYLEA Biologics License Application or BLA for the treatment of neovascular age-related macular degeneration to November 18, 2011, which is a three month extension from the original Prescription Drug User Fee Act action date.
The company said that the extension is a result of the agency classifying recent responses to questions regarding the chemistry, manufacturing, and controls 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.
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