Gilead Sciences (NASDAQ: GILD) has had a tough time branching out into treatment of cystic fibrosis, but today it got some good news. The Foster City, CA-based biotech giant, which has a lung disease research center in Seattle, said today that a panel of expert advisers to the FDA has recommended that the company’s inhalable antibiotic for cystic fibrosis be cleared for sale in the U.S.
The FDA panel voted 15-2 in favor when asked whether Gilead had shown enough evidence that aztreonam lysine was safe and effective, and 17-0 in support of giving the treatment three times a day in a 75 milligram dose. The FDA isn’t required to follow the advice of its review panels, but it usually does. The agency has a deadline of Feb. 13 to complete its review, Gilead said in a statement.
The FDA panel vote is a vindication for Gilead, which obtained the drug through its acquisition of Seattle-based Corus Pharma for $365 million in 2006. Gilead, the world’s largest maker of HIV medicines, saw the Corus cystic fibrosis drug as an important step in its effort to diversify as a maker of treatments for serious lung diseases. The company completed its application for FDA approval of the inhalable antibiotic in November 2007. The drug won clearance for sale in Europe 10 months later, under the brand name Cayston, but the FDA shot down the Gilead application then, saying the company needed to run another clinical trial.
If the drug is cleared for sale, it will be another option for patients with cystic fibrosis, who have a genetic condition that causes buildup of thick, sticky mucus in the lungs that becomes a haven for bacterial infections. About 30,000 patients in the U.S. have the disease.
Gilead was careful in its statements not to crow about victory before the race is over.
“Effectively treating infections in patients with cystic fibrosis is very challenging, and new treatment options are urgently needed,” said Norbert Bischofberger, Gilead’s chief scientific officer, in a statement. “We will continue to work closely with the FDA as it completes its review.”
FDA staff, in briefing documents they prepared for the advisory panel, made some critical remarks about the Gilead drug. Staff remarked that patients who dropped out of one study because of adverse events may have led to biases that favored the new drug, according to this Reuters report. FDA staff also spotted incomplete and vague answers to a patient questionnaire that Gilead used in another study, according to Reuters.