US FDA Approves Oral Antibiotic Utebzi for UTIs

The US Food and Drug Administration (FDA) has approved Utebzi, a new oral antibiotic developed by GlaxoSmithKline (GSK), for the treatment of complicated urinary tract infections (UTIs), including pyelonephritis, a type of kidney inflammation.

Utebzi offers a significant advancement by providing a convenient oral option for managing complicated UTIs that traditionally require hospital-based intravenous (IV) therapy. Complicated UTIs affect more than 2.8 million people annually in the United States and carry a higher risk of serious outcomes compared to uncomplicated infections, which commonly respond well to outpatient oral antibiotics.

Currently, carbapenems—the antibiotic class to which Utebzi belongs—are considered the standard of care for many drug-resistant bacterial infections but have only been available as IV treatments. This often necessitates prolonged hospital stays or specialized outpatient infusion services. Utebzi is the first oral carbapenem approved by the FDA, potentially reducing the need for lengthy hospital admissions by allowing stable patients to complete treatment at home.

Amanda Peppercorn, who leads the development program for the drug at GSK, stated that Utebzi is intended to serve patients within the existing carbapenem treatment group by offering an oral alternative, which may help facilitate earlier hospital discharge and simplify treatment regimens.

The approval follows positive results from a late-stage clinical trial involving 1,690 adult patients hospitalized with complicated UTIs. The trial demonstrated that Utebzi was as effective as imipenem-cilastatin, a broad-spectrum intravenous antibiotic combination currently used to treat these infections. The trial was stopped early due to the compelling efficacy of Utebzi.

GSK expects the drug to be available to patients in the United States by the end of 2026. This addition strengthens GSK’s portfolio of anti-infective medications, alongside Blujepa and Brexafemme, which are also targeted at urinary tract and other infections and are projected to generate substantial annual sales.

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