Gilead Sciences has submitted a Marketing Authorisation Application (MAA) for aztreonam lysine 75 mg powder for nebuliser solution (aztreonam lysine) in the EU. Aztreonam lysine is an investigational therapy in development for people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa) infection. Aztreonam lysine 75 mg powder for nebuliser solution is administered using an eFlow® Nebuliser (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, M.D., senior vice president, head of Respiratory Therapeutics, Gilead Sciences. "The submission of this MAA in the European Union further underscores Gilead's commitment to advancing therapies for patients with this life-threatening disease."
The MAA 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. If approved by the Committee for Medicinal Products for Human Use (CHMP), and validated by the European Medicines Agency (EMEA), it will be available for marketing throughout the EU.
Also, Gilead has appointed John J. Toole, M.D., Ph.D., to the role of senior vice president, Corporate Development. In this role, Dr. Toole will be responsible for setting the strategy for and managing the company's business development and alliance management activities. He will report to John F. Milligan, Ph.D., Gilead's chief operating officer and chief financial officer.
Dr. Toole joined Gilead in 1990 and most recently held the role of senior vice president, Clinical Research. Prior to joining Gilead, he was a founding researcher of Genetics Institute in Cambridge, MA. He also completed postdoctoral fellowships at Harvard Medical School and the Massachusetts Institute of Technology.