Spero Therapeutics' Utebzi Receives FDA Approval for cUTIs

Spero Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted approval for Utebzi (tebipenem pivoxil), an oral antibiotic. Utebzi is approved for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, in adult patients with limited or no alternative oral treatment options. This marks the first and only oral carbapenem antibiotic approved for these patients, stemming from a development and licensing agreement with GSK. The approval was based on positive results from the PIVOT-PO phase III trial, and the drug is expected to be available in the US by the end of 2026.