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Tuesday, February 24, 2009

CFF Response to Azli Rejection

CF Foundation Responds to FDA Decision Requiring More Study of Inhaled Aztreonam

February 19, 2009

The CF Foundation is very disappointed that a much-needed antibiotic treatment for cystic fibrosis will be further delayed. The U.S. Food and Drug Administration (FDA) reviewed data on the potential treatment, aztreonam lysine for inhalation (AZLI) developed by Gilead Sciences, Inc., and determined additional clinical trial data is necessary.

The FDA’s decision, issued yesterday, reiterated its September 2008 ruling that requires Gilead to complete an additional clinical trial for the drug before it will consider approval. Gilead filed a formal appeal with the FDA in November. Yesterday's ruling serves as a denial of the appeal.

The Foundation is exploring all options available to expedite the process of drug approval for AZLI. In the meantime, nearly 300 patients receive the drug through Gilead’s Early Access Program (EAP), which is being conducted in nearly 40 CF care centers nationwide. Gilead will continue to provide early access to AZLI for those CF patients with limited treatment options and a serious risk of disease progression. Individuals with CF should contact their care centers to determine their eligibility to participate in the EAP.

Gilead issued a press release stating that the company has two ongoing clinical studies evaluating this drug. “The company has not yet discussed with the FDA whether or not either of these studies would be sufficient to address the FDA’s requirements or whether Gilead will need to design and conduct a new study.”

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