GSK and Spero Therapeutics have secured FDA approval for Utebzi (tebipenem pivoxil), the first and only oral carbapenem antibiotic for adults with complicated urinary tract infections (cUTIs), including pyelonephritis.
This approval, granted on June 18, 2026, comes four years after the FDA initially rejected Spero's application due to what it deemed an insufficient Phase 3 study in 2022.
Under a 2022 exclusive global licensing deal (excluding certain Asian territories), GSK paid Spero roughly $66 million upfront and up to about $750 million in milestones in exchange for development and commercialization rights, essentially taking over the NDA and regulatory process.
The approval is based on data from the PIVOT‑PO Phase 3 trial, which showed tebipenem pivoxil was non‑inferior to intravenous imipenem‑cilastatin in hospitalized patients with cUTI.
Utebzi is intended for adults with limited or no alternative oral treatment options and is expected to be available in the U.S. by the end of 2026.
Sources:
Fierce Pharma's Post - LinkedIn
SPRO: The fleeting Sparrow - moomoo Community
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