From Reuters.com
By Jackie Frank
GAITHERSBURG, Md., Dec 10 (Reuters) - A U.S. Food and Drug Administration advisory panel on Thursday said it found Gilead Sciences Inc's (GILD.O) aztreonam was an effective new treatment for life-threatening lung infections in cystic fibrosis patients.
The drug won marketing approval in September in Europe and Canada under the brand name Cayston.
The anti-infective drugs panel's finding on a vote of 15-2 that the drug is safe and effective serves as a recommendation that the FDA approve the drug. While the agency is not required to follow an advisory panel's recommendation, the panel's opinion carries great weight.
The panel said the safety and efficacy involved a 75 milligram dose administered three times a day to aid in improvement of respiratory symptoms and lung function.
Azteronam is designed to treat lung infections in these patients caused by common pseudomonas aeruginosa bacteria, for which there are few inhaled antibiotics available.Dr. Bruce Marshall of the Cystic Fibrosis Foundation urged FDA to approve the drug swiftly and told the panel: "There is a desperate need for additional inhaled antibiotics."
Drug resistance is a complication in treatment for these patients.
