Spero Therapeutics says FDA approves Utebzi oral antibiotic for adults with complicated UTIs

Spero Therapeutics, Inc.

Spero Therapeutics, Inc.

SPRO

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  • FDA cleared Utebzi (tebipenem pivoxil) to treat adults with complicated UTIs, including pyelonephritis, when oral options are limited.
  • First oral carbapenem antibiotic approved in the US; GSK holds exclusive global rights under its licensing deal with Spero Therapeutics.
  • Approval backed by Phase III PIVOT-PO data showing non-inferiority versus IV imipenem-cilastatin; US launch expected by end-2026.


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