FDA panel unanimously backs Regeneron eye drug
WASHINGTON (AP) — A panel of federal health experts has unanimously voted in favor of a new eye drug from Regeneron, bringing the company one step closer to competing against a blockbuster Roche drug that currently dominates the market.
A Food and Drug Administration spokeswoman said the agency's advisory panel voted 10-0 that Regeneron's drug preserves eyesight in seniors with a condition that damages the retina and can lead to blindness. More than 200,000 new cases of the condition, called wet macular degeneration, are diagnosed each year.
The FDA is not required to follow the group's advice.
If approved, Regeneron's injectable drug will be the first product to compete with Roche's Lucentis, which posts sales of $1.5 billion annually. The FDA is scheduled to make its final decision on approval by Aug. 20.