Discovery Labs ($DSCO) has finally gained FDA approval for Surfaxin, a surfactant treatment for respiratory distress syndrome in infants that's delivered through an endotracheal tube. The positive regulatory news is long awaited, capping an 8-year series of setbacks over the drug's stability and release mechanisms.
The FDA rejected the drug in 2009 over concerns about the drug's quality through its shelf life and sent Discovery back to do more clinical work. Discovery issued a formal response to those issues late last year.
Plans call for launching Surfaxin commercially in the U.S. late this year. The company says it is the first synthetic peptide-containing surfactant approved for neonatal use, and serves as an alternative to animal-derived surfactants. About 90,000 infants born prematurely in the U.S. are treated with animal-derived surfactants, Discovery Labs says. As a Reuters article on the approval explains, respiratory distress system hits infants born prematurely who can't make enough surfactant on their own. The treatment functions as the natural surfactant does, it coats the inside of the lungs and helps keep them open.
CEO W. Thomas Amick said in a statement that the approval represents "an important medical advancement for the neonatology community and parents of preterm infants." Investors, meanwhile, liked the news and drove the company's shares up 35% in extended trading, Reuters notes.
The company tested the drug on nearly 1,300 patients as part of a massive Phase III multicenter randomized clinical trial. Discovery Labs is also hoping to launch its Afectair ventilator drug delivery system late this year. The FDA cleared the product and European regulatory approval is pending.
- here's the release
- read the Reuters article
- check out FierceBiotech's take