Gilead Submits New Drug Application to FDA
November 16, 2007
Gilead Sciences, Inc. today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration for marketing approval of aztreonam lysine for inhalation (75 mg three times daily), an investigational therapy in development for people with cystic fibrosis who have pulmonary Pseudomonas aeruginosa infection.
The 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. Aztreonam lysine for inhalation is delivered by the eFlow® Electronic Nebulizer (PARI GmbH).
“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,” said A. Bruce Montgomery, MD, senior vice president, head of respiratory therapeutics, Gilead Sciences. “The completion of this new drug application is reflective of Gilead’s commitment to developing novel therapies for people with this life-threatening disease.”
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