Gilead files MAA for aztreonam nebulizer

Gilead Sciences of the USA has submitted a Marketing Authorization Application for approval of aztreonam lysine 75mg powder for nebulizer solution in the European Union. The MAA will be reviewed by the Committee for Medicinal Products for Human Use (CHMP), subject to validation by the European Medicines Agency (EMEA).

Aztreonam lysine is an investigational therapy in development for people with cystic fibrosis who have pulmonary Pseudomonas aeruginosa infection. The product is administered using an eFlow Nebulizer (PARI GmbH).

The MAA is supported by data from two Phase III clinical studies (AIR-CF1 and AIR-CF2) and interim findings of an ongoing open-label extension study (AIR-CF3) of patients who participated in AIR-CF1 or AIR-CF2, Gilead noted.