Gilead Sciences files new drug application with FDA for aztreonam lysine |
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Fri, 16 Nov 2007 19:50
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SAN FRANCISCO (Thomson Financial) - Gilead Sciences Inc. said Friday it submitted a new drug application with the Food and Drug Administration for marketing approval of aztreonam lysine for inhalation, an investigational antibiotic candidate in development for people with cystic fibrosis who have pulmonary Pseudomonas aeruginosa infection.The application is supported by data from two Phase III clinical studies and interim data from an ongoing open-label extension study of patients, the Foster City, Calif.-based biopharmaceutical company said.Aztreonam lysine for inhalation is an investigational therapy and hasn't yet been determined safe or effective in humans, Gilead noted.This proprietary formulation of aztreonam was developed specifically for inhalation and has been designated with orphan drug status in the U.S. and Europe, the company said.Cystic fibrosis is a chronic, debilitating genetic disease characterized by the production of thick mucus in the lungs, which traps bacteria and predisposes patients to lung infections.Shares of Gilead were up $1.02, or 2.3%, at $44.64.Katherine Huntkh/jwCOPYRIGHTCopyright Thomson Financial News Limited 2007. All rights reserved.The copying, republication or redistribution of Thomson Financial News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Financial News.
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