GSK, Spero Win FDA Nod For First-Ever Oral Carbapenem Antibiotic For Complicated UTIs

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 $6 billion in annual healthcare costs. Carbapenems are considered a standard treatment option for severe or resistant infections, but have traditionally been available only through intravenous administration. GSK and Spero said the newly approved oral therapy could provide an alternative that may be used outside hospital settings. Read Also: GSK Makes Its Biggest Bet In More Than A Decade, Paying $10.6 Billion For Cancer Drug Developer Nuvalent Phase 3 Data Supported Approval The FDA’s decision was supported by results from the Phase 3 PIVOT-PO trial. In the study, tebipenem pivoxil demonstrated non-inferiority to intravenous imipenem-cilastatin in hospitalized patients with cUTIs, including pyelonephritis. The oral therapy achieved an overall success rate of 58.5% compared with 60.2% for intravenous imipenem-cilastatin at the test-of-cure visit. The adjusted treatment difference was minus 1.3%, with a 95% confidence interval of minus 7.5% to 4.8%. U.S. Launch Planned By End Of 2026 GSK said Utebzi is expected to become available to patients in the U.S. by the end of 2026. The development of tebipenem pivoxil received partial support from the Biomedical Advanced Research and Development Authority through federal funding. GSK/SPRO Stock Price Activity: GSK shares were up 0.64% at $52.55, and Spero Therapeutics shares were down 18.41% at $2.87 at the time of publication on Wednesday, according to Benzinga Pro data. Image via Shutterstock Read Also: SNAP Stock Slides: Why Wall Street Thinks Snap's Futuristic New Smart Glasses Are Priced Too High