GSK plc (NYSE:GSK) and Spero Therapeutics, Inc. (NASDAQ:SPRO) announced on Wednesday that the U.S. Food and Drug Administration has approved Utebzi (tebipenem pivoxil hydrobromide), an oral antibiotic for adults with complicated urinary tract infections (cUTIs).

First Oral Carbapenem Approved For This Patient Population

The indication includes pyelonephritis, caused by certain susceptible pathogens, and patients who have limited or no alternative oral treatment options.

The companies said Utebzi is the first and only oral carbapenem antibiotic approved for this patient population.

The approval stems from GSK’s development and exclusive global licensing agreement with Spero Therapeutics, excluding select Asian territories.

Complicated UTIs affect more than 3 million people annually in the U.S., according to the companies.

Treatment failure occurs in as many as 34% of patients, while infections caused by multidrug-resistant pathogens contribute more than ...