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news.Gilead Sciences' Phase III clinical trial evaluating Cayston (aztreonam for inhalation solution) versus tobramycin inhalation solution (TIS) in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P aeruginosa) has attained one of its co-primary endpoints of non-inferiority for mean percent change in forced expiratory volume in one second (FEV1) percent predicted after 28 days of treatment.
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Gilead Sciences’ study showed that the patients receiving Cayston had a mean increase in FEV1 percent predicted from baseline to day 28 of 8.35% compared to 0.55% for patients receiving TIS, which meets the statistical definition of superiority. These data were presented during a late-breaker oral session at the 33rd European Cystic Fibrosis Conference (ECFC) in Valencia, Spain.
Cayston has received approval from FDA and the Australian Therapeutic Goods Administration (TGA) in February 2010 and in January 2010, respectively. Cayston received conditional marketing authorisations in the EU and Canada in September 2009. These conditional approvals are dependent on results from this Phase III study.
Norbert Bischofberger, executive vice president of research and development and chief scientific officer at Gilead Sciences, said: “Given the chronic nature of pseudomonal infection and the potential for antibiotic resistance, it is important that cystic fibrosis patients have multiple treatment options.”