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GSK : Utebzi (tebipenem pivoxil) approved in the US for adults with complicated urinary tract infections (cUTIs)
GSK : Utebzi (tebipenem pivoxil) approved in the US for adults with complicated urinary tract infections
About this update from Gsk Plc
GSK plc (LSE/NYSE: GSK) and Spero Therapeutics (Nasdaq: SPRO) today announced that the US Food and Drug Administration (FDA) has approved Utebzi, an oral antibiotic for the treatment of complicated urinary tract infections (cUTIs) including pyelonephritisa, caused by certain susceptible pathogensb in adult patients who have limited or no alternative oral treatment options. This is the first and only oral carbapenem antibiotic approved for these patients. This approval is a result of GSK's development and exclusive global licensing agreement (excluding select Asian territories) with Spero Therapeutics.4 There are more than 3 million cases of cUTI in the US annually and treatment failure impacts up to 34% of patients.2,3 Often caused by multidrug-resistant pathogens,5 these infections account for over $6 billion per year in healthcare costs.6 Carbapenems are the standard treatment for severe or resistant infections, but until now have only been available through intravenous administration7, increasing hospital resource use and reducing patients' quality of life.8 Tebipenem pivoxil offers the potential for an effective oral alternative taken outside of a hospital setting. Tony Wood, Chief Scientific Officer, GSK, said: "With antibiotic resistance continuing to rise, patients and healthcare professionals need new treatment options. The approval of Utebzi provides the first and only oral carbapenem antibiotic for appropriate adults with complicated UTIs, a solution that could help reduce reliance on hospital-based intravenous care and support efforts to address resistant infections." Dr. Bilal Chughtai, Chief of Urology at Plainview Hospital, Northwell Health and Associate Professor of Urology at the Zucker School of Medicine at Hofstra/Northwell, said: "For patients with complicated urinary tract infections (cUTIs) and their caregivers, this approval is a major milestone as today's standard of care places a serious burden on them and hospitals. A new effective oral treatment offering an alternative option to intravenous care has the potential to enable more treatment in the outpatient settings with the ambition to improve their experience." Esther Rajavelu, President and Chief Executive Officer, Spero Therapeutics added: "The FDA approval of tebipenem pivoxil marks the culmination of more than a decade of dedication from our team, partners, and, most importan...