FDA advisory committee recommends approval for Novartis cystic fibrosis drug
EAST HANOVER, N.J. — A panel of Food and Drug Administration experts is recommending that the agency approve an experimental drug for cystic fibrosis made by Novartis, the Swiss drug maker said.
The FDA Anti-Infective Drug Advisory Committee voted 13-1 in favor of approval for tobramycin inhalation powder in patients with cystic fibrosis whose lungs contain Pseudomonas aeruginosa bacteria, or Pa, which is the leading cause of loss of lung function in people with the disease. The FDA is not bound by advisory committee votes when deciding whether or not to approve a drug, but usually follows them.
The panel's recommendation was based on results of three phase-3 studies of tobramycin inhalation powder in more than 650 patients aged 6 and older, of whom 425 received at least one dose of the drug. Novartis said the studies found that treatment with the drug improved lung function.