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U.S. Food and Drug Administration Advisory Panel Rules in Favor of CF Antibiotic by Gilead Sciences

December 10, 2009

A potential CF drug called aztreonam lysine for inhalation was today recommended for approval by an advisory panel to the U.S. Food and Drug Administration (FDA).

Aztreonam lysine for inhalation (AZLI) is being developed by Gilead Sciences, Inc. The drug would offer a much-needed antibiotic alternative for cystic fibrosis patients who battle recurrent lung infections and often develop resistance to existing antibiotics.

“We are very pleased with the FDA advisory panel’s recommendation to approve this drug. Inhaled aztreonam is sorely needed by cystic fibrosis patients and their doctors to treat lung infections, which are the major cause of death in this disease,” said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation. "This drug is already approved in Europe and Canada, and we urge the FDA to expedite its approval process so that CF patients in the U.S. will have access to this important new antibiotic as soon as possible."

The Cystic Fibrosis Foundation asked two CF doctors and a CF patient to testify in favor of approval of the drug before the FDA panel today. The doctors included Bruce Marshall, M.D., vice president of Clinical Affairs at the Cystic Fibrosis Foundation, and Patrick Flume, M.D., center director of the CF Center at the Medical University of South Carolina.

Beth Sufian, a lawyer from Houston who has CF, urged the panel to give a positive ruling on the drug.

“Access to inhaled aztreonam will give children and adults with CF the opportunity to live a better life,” Sufian explained to the panel. “You have the power to change the lives of people with CF who struggle every day just to breathe.”

The FDA will consider today’s recommendation from the panel and rule on whether or not to approve inhaled aztreonam as a drug in the United States at a future date not yet determined.

The Foundation will continue to press the FDA to approve the drug swiftly so that it can be made available to people with CF as soon as possible.

Inhaled aztreonam was developed as a result of a Therapeutics Development Award from the Cystic Fibrosis Foundation. If it receives FDA approval, it will the be first drug supported by such an award approved specifically for the treatment of cystic fibrosis.

The Cystic Fibrosis Foundation is an accredited charity of the Better Business Bureau.