For Discovery Laboratories, the fifth try proved the charm. FDA regulators have finally stamped an approval on Surfaxin as a guard against respiratory distress syndrome in infants after four rejections spread out over an 8-year regulatory odyssey.
"This is an ecstatic moment for us," Discovery President John G. Cooper told The New York Times. "It took time, but good things usually do take time."
Reuters notes that the market Discovery plans to tackle later in the year is worth up to about $70 million. And investors celebrated the approval by bidding up shares ($DSCO) by about 40% in pre-market trading.
The FDA's approval was notable for its lack of enthusiasm, citing four other surfactants already approved for the market. But Discovery--which has had to answer a long list of FDA questions on manufacturing, quality and drug stability over the years--believes that the first synthetic treatment to hit the market will have a decided edge over its rivals. Their approval, though, doesn't give them a chance to boast about an advantage over products derived from animals.
The therapies are used to treat infants who don't naturally produce enough surfactant--a liquid coating in the lungs that prevents them from collapsing.
- here's the FDA's press release
- get The New York Times story
- read the Reuters report