FDA Approves First Oral Carbapenem for Complicated Urinary Tract Infections

The U.S. Food and Drug Administration (FDA) has approved Utebzi (tebipenem pivoxil) as the first oral carbapenem antibiotic for the treatment of complicated urinary tract infections (UTIs). This approval marks an important advancement in the management of complicated UTIs by providing an effective oral alternative to intravenous carbapenem therapy, potentially improving treatment convenience and expanding outpatient care options for appropriate patients.

Condition

A UTI is an infection in any part of the urinary system, such as the kidneys, ureters, bladder and urethra. Most infections involve the lower urinary tract — the bladder and the urethra. Women have a higher risk of getting UTIs than men. cUTIs can have more severe symptoms compared with uncomplicated UTIs, including pain in the lower back, fever, chills, nausea and vomiting. cUTIs may be in the lower or upper urinary tract and are more likely to be caused by drug-resistant bacteria.

Data Supporting Utebzi

The efficacy of Utebzi was evaluated in adults with cUTI, including pyelonephritis, in a global, randomized, double-blind, double-dummy, noninferiority trial (NCT06059846). In this trial, 1,690 hospitalized patients were randomly assigned to receive Utebzi 600 mg orally every 6 hours or imipenem-cilastatin 500 mg intravenously every 6 hours for 7 to 10 days. A total of 929 patients were considered the “intent-to-treat” population.

Efficacy was assessed in the intent-to-treat population as a composite of clinical cure (resolution of signs and symptoms of infection) and microbiological response (reduction of baseline pathogens) at a follow-up visit. The composite response rates showed that Utebzi’s effectiveness was comparable to imipenem-cilastatin.

Safety Information

The most common side effects are diarrhea, headache, nausea, abdominal pain, increased liver enzymes, and Clostridioides difficile infection. Patients with allergic reactions to Utebzi or other beta-lactam antibacterials should not take Utebzi, nor should patients with primary or secondary carnitine deficiency or inborn metabolism errors that may result in clinically significant carnitine deficiency. More safety information is included in the prescribing information.

Utebzi received priority review, fast track, and Qualified Infectious Disease Product Designation for this indication.