CF Foundation Urges Swift FDA Review of AZLI Antibiotic

December 15, 2009

The CF Foundation today asked FDA Commissioner Margaret Hamburg for swift review of aztreonam lysine for inhalation (AZLI) — a new drug for the treatment of cystic fibrosis.

The Foundation urged the agency to move quickly to make the drug available to patients. This action follows a recommendation last week by an independent advisory panel that the FDA should approve the drug for use.

The drug is already approved in Europe and Canada.

“AZLI is an antibiotic that would offer a much-needed alternative for CF patients who battle recurrent lung infections and often develop resistance to existing antibiotics,” said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation. “Lung infections are the leading cause of death in cystic fibrosis and AZLI would fill a critical need.” It is being developed by Gilead Sciences, Inc.

A letter to the FDA commissioner from Dr. Beall and Executive Vice President for Medical Affairs Preston W. Campbell, III, M.D., asks the FDA to expedite the approval process for the drug so that CF patients will have access to it as soon as possible.

Beth Sufian, a lawyer from Houston who has CF, testified before the advisory panel last week. “You have the power to change the lives of people with CF who struggle every day just to breathe,” she said. Read her full testimony.

AZLI was developed as a result of a therapeutics development award from the Cystic Fibrosis Foundation. If it receives FDA approval, it will be the first drug supported by such an award approved specifically for the treatment of cystic fibrosis.
If you’d like to contact the FDA to encourage the agency to approve this drug, please follow these guidelines.