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FDA Approves Regeneron's Eye Injection Eylea

By: AP
Posted: Fri 4:23 PM, Nov 18, 2011

NEW YORK (AP) -- Regeneron Pharmaceuticals Inc. says regulators approved marketing of its eye drug Eylea, an injection designed to treat a common cause of blindness in senior citizens.

Eylea is intended to treat "wet" age-related macular degeneration. More than 200,000 cases are diagnosed in the U.S. every year. The only other drug approved for the condition is Roche's Lucentis, which was approved in 2006 and posts $1.5 billion in annual sales.

A Food and Drug Administration advisory panel unanimously recommended approval for Eylea in June, but in August, the FDA extended its review of the drug by three months to review additional data.

If the drug is approved in other markets, Bayer HealthCare will market Eylea and the companies will split the profits.


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