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FDA Anti-Infective Drug Advisory Committee recommends aztreonam for treatment of P. aeruginosa in patients with cystic fibrosis

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The FDA Anti-Infective Drug Advisory Committee has voted in favor of the efficacy and safety of a 75 mg, three-times-daily formulation of aztreonam (Azli, Gilead), 15-2.

The committee discussed a new drug application for inhaled aztreonam for the proposed indication of improvement of respiratory symptoms and pulmonary function in cystic fibrosis patients with Pseudomonas aeruginosa.

Researchers from Gilead and the FDA presented data on twice-daily and three-times-daily formulations of the drug which had been tested vs. placebo. Public petitions were made and the vote was cast.

There were two questions voted on by the committee:

1.Has the applicant provided substantial evidence of efficacy and safety of 75 mg three-times-daily of Azli for the requested indication of improvement of respiratory symptoms and pulmonary function in cystic fibrosis patients with Pseudomonas aeruginosa?

2.Has the applicant identified the correct dose and regimen of Azli for the requested indication?

The vote on the first question was 15-2 in favor, with no abstentions.

The vote on the second question was 17-0 in favor, with no abstentions.

Panel members cited reasons for voting in favor of the drug. Many discussed the combination of the morbidity and mortality associated with the disease and the lack of treatment options. Though aztreonam may be a flawed drug, using it may be a better option than using off-label antibiotics, which many patients do.

Another common opinion expressed was that though the evidence presented in favor of aztreonam was not incontrovertible, it was substantial enough to warrant approval. This opinion was also expressed as a reason for voting in favor of the three-times-daily 75 mg dose.

Several panel members said that different doses and dosing schedules for aztreonam should be explored. There were concerns about the pharmacokinetics and half-life in relationship with the minimum inhibitory concentration. Panel members suggested trials of other doses and schedules, but no consensus has been reached.