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FDA delays Regeneron Eylea BLA review

The US Food and Drug Administration (FDA) has delayed the review of Regeneron Pharmaceuticals' Eylea biologics license application (BLA) to 18 November 2011.

Eylea is indicated as a treatment for neovascular age-related macular degeneration (wet AMD).

The extension of three months follows the recent amendment made by the company on the chemistry, manufacturing and controls (CMC) section of the BLA.

The new action date will give the agency additional time to review the information submitted.