Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the
Anti-Infective Drugs Advisory Committee of the U.S. Food and Drug
Administration (FDA) has recommended that aztreonam for inhalation
solution be approved for the treatment of infections due to Pseudomonas
aeruginosa (P. aeruginosa) in patients with cystic fibrosis
(CF). The committee voted 15 to 2 that Gilead has provided
sufficient evidence of the safety and efficacy of aztreonam for
inhalation solution. The panel also voted 17 to 0 that aztreonam for
inhalation solution 75 mg three times daily is a correct dose and
regimen.
The recommendations of the Advisory Committee are not binding but will
be considered by the FDA as the agency completes its review of Gilead’s
application. The FDA has established a target review date, under the
Prescription Drug User Fee Act (PDUFA), of February 13, 2010. In the
interim, Gilead will continue to make the product available through its
Expanded Access Program in the United States.
“Effectively treating infections in patients with CF is very
challenging, and new treatment options are urgently needed,” said
Norbert Bischofberger, PhD, Executive Vice President, Research and
Development and Chief Scientific Officer, Gilead Sciences. “We will
continue to work closely with the FDA as it completes its review of
aztreonam for inhalation solution.”