FDA Bestows SPA for Achaogen Antibiotic Trial
By Catherine Shaffer
Monday, September 23, 2013
A Phase III trial of Achaogen Inc.’s plazomicin for serious multidrug-resistant gram-negative bacterial infections will be carried out through a special protocol assessment (SPA) under a new agreement with the FDA. The trial will assess safety and efficacy of the drug compared with colistin in patients with bloodstream infections and nosocomial pneumonia caused by carbapenem-resistant Enterobacteriaceae.
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