Gilead submits new drug application for cystic fibrosis treatment

The new drug application (NDA) is supported by data 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 (CFQ-R), a patient-reported outcome tool used to measure health-related quality of life for people with cystic fibrosis. AIR-CF2 data demonstrated that aztreonam lysine for inhalation significantly delayed the time to need for inhaled or intravenous (IV) antibiotics following a course of inhaled tobramycin.

Both studies demonstrated improvements from baseline in respiratory function, as measured by relative improvement of forced expiratory volume in one second (FEV1) compared to placebo. Aztreonam lysine for inhalation is an investigational therapy and has not yet been determined safe or efficacious in humans.

Bruce Montgomery, senior vice president, head of respiratory therapeutics at Gilead Sciences, said: “Chronic pseudomonal airway infection represents the single greatest cause of morbidity and mortality for people with cystic fibrosis, and with a limited number of inhaled antibiotics, there remains a significant unmet medical need. The completion of this new drug application is reflective of Gilead’s commitment to developing novel therapies for people with this life-threatening disease.”