UPDATE 2-FDA knocks back Achaogen's drug for bloodstream infection [Reuters]
ACHAOGEN (AKAO)
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Source: Reuters
FDA knocks back Achaogen's drug for bloodstream infection | Reuters 3 Min Read (Reuters) - The U.S. Food and Drug Administration cleared Achaogen Inc’s antibiotic to treat adults with complicated urinary tract infections, but shares slumped 25 percent as the drug failed to win approval for treating bloodstream infections. The agency cited lack of evidence of effectiveness of the drug, Zemdri, in a clinical study to treat bloodstream infections, the company said in a statement. Investors had hoped that the drug would win approval for treating both types of infections, Wedbush analyst Robert Driscoll said. The treatment, previously known as plazomicin, had a “breakthrough therapy” status reserved for serious diseases that do not have approved treatments in the market. The FDA decision follows similar recommendations by its independent panel, known as AdComm, in May. Despite the drug’s failure to win approval for treating bloodstream infections, the company expects it to be used in some
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