The company noted that a Phase III AIR-CF2 (CP-AI-005) 247-patient study of aztreonam lysine for inhalation for the treatment of people with cystic fibrosis who have pulmonary Pseudomonas aeruginosa met its primary efficacy endpoint, the time to need for inhaled or intravenous antibiotics. Full study results will be presented at an upcoming scientific meeting.
The most common adverse events were cough, productive cough, nasal congestion, respiratory tract congestion and wheezing but Gilead noted that the incidence of these events did not differ significantly between the placebo and the aztreonam lysine groups.
Ambrisentan filed with FDA
The encouraging data comes days after Gilead asked the US Food and Drug Administration to approve its new pulmonary arterial hypertension treatment ambrisentan, which it gained access to through its $2.5 billion buyout of Myogen. GlaxoSmithKline holds rights to the compound outside the USA.