Aztreonam used in inhalers to treat Pseudomonas aeruginosa infections in patients with cystic fibrosis (CF) has been approved by a US Food and Drug Administration (FDA) committee.
The anti-infective drugs advisory committee says that Gilead Sciences has proved the drug’s safety, and recommends a regime of 75mg three times a day.
Advisory committee recommendations are not binding, but will be considered by the FDA as the agency completes its review of Gilead’s application.
A review date of February 13 next year under the Prescription Drug User Fee Act (PDUFA) has been scheduled. Gilead will meanwhile continue to make the product available in the US through its expanded-access programme.
Says Gilead spokesman Norbert Bischofberger: “Effectively treating infections in patients with CF is very challenging, and new treatment options are urgently needed. We will continue to work closely with the FDA as it completes its review of aztreonam for inhalation solution.”
Copyright Press Association 2009