Topic: FDA approves first oral carbapenem for complicated urinary tract infections
The FDA has approved Utebzi (tebipenem pivoxil), the first oral carbapenem antibiotic in the United States, for adults with complicated urinary tract infections (cUTIs), including pyelonephritis, caused by susceptible bacteria when alternative oral treatment options are limited or unavailable.
Approval was based on the phase 3 PIVOT-PO trial involving 1,690 hospitalized patients, where oral tebipenem demonstrated similar efficacy to IV imipenem-cilastatin. This offers a potential outpatient or oral step-down treatment option for selected patients who would otherwise require prolonged intravenous carbapenem therapy.
The drug is active against several common uropathogens, including E. coli, Klebsiella pneumoniae, Enterobacter cloacae complex, Klebsiella oxytoca, and Enterococcus faecalis. As with all carbapenems, use should be guided by culture and susceptibility testing to help preserve antimicrobial effectiveness.
Clinical takeaway: Utebzi is the first FDA-approved oral carbapenem, providing a new treatment option for resistant complicated UTIs and potentially reducing the need for prolonged hospitalization and IV antibiotic therapy.
Link: https://t.co/BPqZMZjQvB