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

GSK and Spero Therapeutics announced FDA approval of Utebzi (tebipenem pivoxil hydrobromide), the first oral carbapenem antibiotic for treating complicated urinary tract infections including pyelonephritis. The drug demonstrated non-inferiority to intravenous imipenem-cilastatin in Phase 3 trials and is expected to launch in the U.S. by end of 2026, offering an alternative to hospital-based IV treatments for the 3+ million Americans annually affected by cUTIs.