FDA Extends Target Date for Review of Eye Drug
TARRYTOWN, N.Y. (AP) - Regeneron Pharmaceuticals Inc. said Tuesday that the Food and Drug Administration has pushed back its target date for completing its review of the company's experimental eye drug, Eylea, by three months.
The agency now will look to complete its review of the drug by Nov. 18.
Regeneron shares tumbled more than 7 percent in aftermarket trading.
The FDA needs more time to review recent responses as part of Regeneron's bid to obtain a license for the drug as a treatment for "wet" age-related macular degeneration, a common cause of blindness.
If Eylea is approved, it would be the first drug to compete with Roche's Lucentis.
In June, Bayer filed for approval of Eylea as a treatment for wet age-related macular degeneration in Europe and Japan.
Bayer HealthCare will market Eylea outside the United States, where the companies will share equally the profits from any future sales of EYLEA.
Shares of Regeneron fell $4.27 to $53.15 in aftermarket trading. The shares slipped 75 cents to $57.42 during the regular session.
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Posted: August 2011