Gilead Submits MAA for Aztreonam Lysine 75 mg Powder for Nebuliser, for cystic fibrosis to EMA

Mar 7, 2008 - Gilead Sciences, Inc. (Nasdaq:GILD) today announced the submission of a Marketing Authorisation Application (MAA) for marketing approval of aztreonam lysine 75 mg powder for nebuliser solution (aztreonam lysine) 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). Review of the MAA will be conducted by the EMEA under the centralized licensing procedure, which, when finalized, provides one marketing authorization in all member states of the European Union. 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(R) Nebuliser (PARI GmbH).

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.