June 26, 2018
By Reuters Staff
(Reuters) - Achaogen Inc said on Tuesday U.S. health regulators cleared its antibiotic Zemdri (plazomicin) to treat adults with complicated urinary tract infections, but declined approval for treating bloodstream infections.
The U.S. Food and Drug Administration cited lack of evidence of effectiveness of the drug in a clinical study to treat bloodstream infections, the company said in a statement.
"We see limited impact on future revenues if plazomicin's label does not include (bloodstream infections)," Wedbush analyst Robert Driscoll said in an interview last week.
The FDA decision on the drug follows similar recommendations by an independent panel to the regulator in May.
The drug is approved for complicated urinary tract infections, including pyelonephritis, caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Enterobacter cloacae, in patients who have limited or no alternative treatment options. Zemdri is an intravenous infusion, administered once daily.
The condition has other approved treatments in the market, including Vabomere (meropenem and vaborbactam), developed by Medicines Co unit Rempex Pharmaceuticals and approved for complicated urinary tract infections caused by E. coli, K. pneumoniae, and Enterobacter cloacae species complex.
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