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FDA Approves First Oral Carbapenem for Adults
23 Jun
Summary
- Utebzi is the first oral carbapenem antibiotic approved for adults.
- It is indicated for complicated urinary tract infections, including pyelonephritis.
- The drug is expected to be available in the U.S. by the end of 2026.
The U.S. Food and Drug Administration has granted approval for Utebzi (tebipenem pivoxil hydrobromide), a groundbreaking oral antibiotic for adult patients battling complicated urinary tract infections (cUTIs). This marks a pivotal moment as Utebzi becomes the first and only oral carbapenem antibiotic to receive FDA approval for this specific patient group.
The approval encompasses treatment for pyelonephritis, caused by certain susceptible pathogens, and is particularly crucial for individuals with limited or no alternative oral treatment options. The development stems from a collaboration between GSK and Spero Therapeutics.
Complicated UTIs affect millions annually in the U.S., with treatment failure rates reaching as high as 34%. Infections involving multidrug-resistant pathogens contribute substantially to healthcare costs. Carbapenems, traditionally administered intravenously, are vital for severe or resistant infections.
GSK has announced plans to make Utebzi available to patients in the U.S. by the end of 2026. The FDA's decision was informed by Phase 3 PIVOT-PO trial data, which demonstrated tebipenem pivoxil's non-inferiority compared to intravenous imipenem-cilastatin in hospitalized patients with cUTIs.
This oral therapy offers a potential alternative to intravenous treatments, enabling outpatient management and potentially reducing hospitalizations. The development of tebipenem pivoxil received partial support from the Biomedical Advanced Research and Development Authority.
