ARTICLE | Regulation

No rush, then judgment

December 14, 2009 8:00 AM UTC

An FDA advisory panel brushed off the agency's concerns about results of a Phase III trial of Cayston inhaled aztreonam lysine from Gilead Sciences Inc. that have delayed approval of the antibiotic for more than a year. Instead, the Anti-Infective Drugs Advisory Committee relied on secondary endpoints and data from other Phase III trials to endorse Cayston to treat cystic fibrosis patients with Pseudomonas aeruginosa infections.

FDA has been asking for an additional trial of the inhaled cephalosporin antibiotic since it issued a complete response letter in 2008. Gilead declined to do that, instead submitting a reanalysis of the data...