MAA submitted for cystic fibrosis drug

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Gilead Sciences Inc has submitted a marketing authorisation application (MAA) for aztreonam lysine 75mg powder for nebuliser solution (aztreonam lysine) in the EU.

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 centralised licensing procedure, which when finalised provides a single marketing authorisation in all EU member states.

Aztreonam lysine is an investigational therapy in development for people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa infection.

Gilead