Gilead Submits NDA for Aztreonam Lysine

Gilead Sciences has sent the FDA a new drug application (NDA) for marketing approval of aztreonam lysine for inhalation, an investigational therapy in development for patients with cystic fibrosis who have pulmonary pseudomonas aeruginosa infection.

The NDA is supported by data from two Phase III studies and interim data from an ongoing open-label extension, Gilead said.

In August, Gilead started an expanded access program to provide aztreonam lysine to those who have limited treatment options and are at risk for disease progression.