The MAA will be reviewed by the Committee for Medicinal Products for Human Use (CHMP), subject to validation by the European Medicines Agency. Aztreonam lysine is an investigational therapy for people with cystic fibrosis who have pulmonary Pseudomonas aeruginosa infection. Aztreonam lysine 75mg powder for nebuliser solution is administered using an eFlow Nebuliser.
Bruce Montgomery, senior vice president, head of respiratory therapeutics, Gilead Sciences, said: “The submission of this MAA in the EU further underscores Gilead’s commitment to advancing therapies for patients with this life-threatening disease.”