It's taken Gilead Sciences longer than it expected, but the developer has just taken a giant step toward FDA approval of its experimental cystic fibrosis drug. An expert FDA advisory panel yesterday turned in a 15 to 2 vote in favor of the aztreonam's safety and efficacy and unanimously backed a 75-milligram dose taken three times a day.
About 30,000 Americans suffer from the disease, a genetic ailment that causes the accumulation of mucus in the lungs. As Xconomy notes, yesterday's vote signals a big payoff for Gilead, which bought Corus Pharma three years ago for $365 million--largely due to the promise of its CF program. European approval came in 2008, but Gilead ran into a major roadblock at the FDA, which demanded a new clinical trial.
"Effectively treating infections in patients with CF is very challenging, and new treatment options are urgently needed," said Norbert Bischofberger, PhD, Gilead's chief scientific officer. "We will continue to work closely with the FDA as it completes its review of aztreonam for inhalation solution."
- read the article from Xconomy
- here's Gilead's release