Gilead submits inhalable aztreonam NDA

US drugmaker Gilead Sciences has submitted a New Drug Application to the Food and Drug Administration seeking marketing approval of aztreonam lysine for inhalation (75mg three times daily), an investigational therapy in development for people with cystic fibrosis who have pulmonary Pseudomonas aeruginosa infection. The NDA is supported by findings from two Phase III clinical studies (AIR-CF1 and AIR-CF2) and interim data from an ongoing open-label extension study (AIR-CF3) of patients who participated in AIR-CF1 or AIR-CF2.

Data from AIR-CF1 demonstrated improvement in respiratory symptoms for people with cystic fibrosis as measured by the Respiratory Symptoms scale of the Cystic Fibrosis Questionnaire-Revised, a patient-reported outcome tool used to measure health-related quality of life for people with cystic fibrosis. AIR-CF2 data demonstrated that aztreonam for inhalation significantly delayed the time to need for inhaled or intravenous antibiotics following a course of inhaled tobramycin, Gilead noted. It added that both studies also demonstrated improvements from baseline in respiratory function, as measured by relative improvement of forced expiratory volume in one second compared to placebo.