FDA panel backs Gilead's Cayston

FDA's Anti-Infective Drugs Advisory Committee voted 15-2 that Cayston inhaled aztreonam lysine from Gilead Sciences Inc. (NASDAQ:GILD) is a safe and efficacious treatment to improve respiratory symptoms and pulmonary function in cystic fibrosis patients with Pseudomonas aeruginosa infections. While the agency raised concern over the primary endpoint of time to need for antibiotics in the Phase III Study CP-AI-005, the panel was reassured by the compound's performance on the secondary endpoint of forced expiratory volume measured in one second (FEV1), plus the results from Study CP-AI-006, a Phase III open-label extension study. In Study CP-AI-005, Cayston increased FEV1 by 6.28% (p=0.0012) from baseline vs. placebo. Patients were able to maintain increases in FEV1 while on Cayston during the 18-month extension study.

The panel voted 17-0 that Gilead's proposed dose of 75 mg three times/day was the correct dose regimen for the indication. The agency had proposed that Gilead conduct an additional trial to study 150 mg of Cayston given twice daily. ...