FDA approval of Regeneron’s Eylea delayed by 3 months
TARRYTOWN, N.Y. (AP) — Earlier on Tuesday, Regeneron Pharmaceuticals Inc. announced that FDA review of the company’s experimental eye drug, Eylea, has been postponed by 3 months from the anticipated date, and the agency is expected to complete drug review by Nov 18.
In aftermarket trading, Regeneron shares slipped over 7 percent.
The drug has been developed for the treatment of “wet” age-related macular degeneration that very often leads to blindness. The FDA has requested more time to evaluate recent responses as a part of Regeneron’s proposal to procure a drug license for this indication.
Roche’s Lucentis is used to treat wet age-related macular degeneration, and approval of Eylea will make it the first drug to compete with Lucentis.
In Europe and Japan, Bayer applied for FDA approval of Eylea in June.
Outside the United States, Bayer HealthCare is responsible of marketing Eylea, and both the companies are said to share equal profits arising from any future sales of EYLEA.
In aftermarket trading, Regeneron shares plummeted $4.27 to $53.15. During the regular season, the shares slumped 75 cents to $57.42.