The US FDA has approved tebipenem pivoxil, an oral carbapenem antibiotic, for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, in adults with limited or no alternative oral treatment options. The approval is specifically for cUTIs caused by susceptible microorganisms, including Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex, Klebsiella oxytoca, and Enterococcus faecalis .
Clinical evidence In a clinical trial involving 1,690 hospitalized patients with cUTI or pyelonephritis, tebipenem pivoxil demonstrated a composite response rate of 58.5% for clinical cure and microbiological response, compared with 60.2% for imipenem-cilastatin. Clinical cure was achieved in 93.5% of patients receiving tebipenem pivoxil versus 95.2% with imipenem-cilastatin, while microbiological response rates were 60.3% and 61.3%, respectively.…
