(Reuters) – Achaogen Inc said on Tuesday U.S. health regulators cleared its antibiotic 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, previously known as plazomicin, 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, Zemdri, follows similar recommendations by an independent panel to the regulator in May.
Shares of the company were halted before the bell.
Complicated urinary tract infection is a painful condition, which occurs in people with functional or structural abnormalities of the urinary tract and is characterized by fever, chills and back pain.
The condition has other approved treatments in the market, including Vabomere, developed by Medicines Co unit Rempex Pharmaceuticals.
Reporting by Sharnya G and Manas Mishra in Bengaluru; Editing by Anil D’Silva