Gilead Sciences has moved a step closer to getting approval for its cystic fibrosis treatment in the USA.

The US Food and Drug Administration’s Anti-Infective Drugs Advisory Committee has recommended that the company’s aztreonam for inhalation solution be approved for the treatment of infections due to Pseudomonas aeruginosa in patients with CF. The panel voted 15 to 2 that Gilead has provided “sufficient evidence of the safety and efficacy” of the drug and 17 to 0 that 75mg three times daily is the correct dose.

The FDA has set a Prescription Drug User Fee Act date of February 13 to decide whether to give the green light to drug, and in the meantime, Gilead said it continue to make aztreonam available through an expanded access programme in the USA. The drug won conditional marketing approval in September in the European Union and Canada under the trade name Cayston.

Just over a year ago, the FDA rejected aztreonam, saying that an additional clinical study is required. Now, despite the panel’s recommendation, Gilead is not counting its chickens just yet and chief scientific officer Norbert Bischofberger said that “we will continue to work closely with the FDA as it completes its review”, noting that “effectively treating infections in patients with CF is very challenging, and new treatment options are urgently needed”.

The USA’s Cystic Fibrosis Foundation is a fan of the drug and asked two doctors and a CF patient to testify in favour of approval before the FDA panel. The foundation’s chief executive, Robert Beall, said “we urge the FDA to expedite its approval process so that CF patients in the USA will have access to this important new antibiotic as soon as possible”.