FDA Approves Fosfomycin for Complicated Urinary Tract Infections
The FDA has approved fosfomycin (Contepo) for injection to treat adults with complicated urinary tract infections (cUTIs), including acute pyelonephritis, caused by susceptible strains of Escherichia coli and Klebsiella pneumoniae, according to Meitheal Pharmaceuticals.
About Fosfomycin
Fosfomycin is an intravenous epoxide antibacterial antibiotic effective against gram-negative bacteria such as E. coli and K. pneumoniae that cause cUTIs. Importantly, it has no known cross-resistance with other antibiotic classes.
"The rise of multi-drug-resistant pathogens poses a significant threat to our ability to combat infectious diseases, underscoring the continued need for novel therapies that target resistant organisms in patients having cUTIs," said Keith S. Kaye, MD, MPH, Chief of the Division of Allergy, Immunology and Infectious Diseases at Robert Wood Johnson Medical School.
Supporting Clinical Evidence
The approval is based on the phase 2/3 ZEUS trial (NCT02753946), which demonstrated that intravenous fosfomycin was noninferior to piperacillin/tazobactam. The trial's primary endpoint was overall success—combining clinical cure and microbiological eradication—measured at the test-of-cure visit on day 19 in the microbiological intent-to-treat population.
- Overall success was 63.5% (108 of 170 patients) in the fosfomycin group
- Comparison group with piperacillin/tazobactam had a success rate of 55%
This data supports fosfomycin as a valuable treatment option for complicated urinary tract infections, especially considering antibiotic resistance challenges.
Author's Summary
Fosfomycin’s FDA approval introduces a critical intravenous option for treating drug-resistant complicated urinary tract infections, backed by robust clinical trial evidence.