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FDA approved Utebzi (tebipenem pivoxil), the first and only oral carbapenem antibiotic in the US, for adults with complicated urinary tract infections who have limited or no alternative oral options. The approval is based on the PIVOT-PO Phase 3 trial showing non-inferiority to IV imipenem-cilastatin. GSK holds exclusive global rights (excluding select Asian territories) and plans US launch by end of 2026.
EX-99.1 2 d51395dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Utebzi (tebipenem pivoxil) approved in the US for adults with complicated urinary tract infections (cUTIs) • First and only oral carbapenem antibiotic approved in the US • Approval based on PIVOT-PO trial demonstrating non-inferiority compared to intravenous treatment 1 • More than 3 million cases of cUTIs are treated annually in the US with a third of patients impacted by resistant infections 2 , 3 CAMBRIDGE, Mass., June 17, 2026 — Spero Therapeutics, Inc . (Nasdaq: SPRO) and GSK plc (LSE/NYSE: GSK) 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 pyelonephritis a , caused by certain susceptible