India, June 17 -- GSK plc (GSK) and Spero Therapeutics (SPRO) announced that the U.S. FDA has approved Utebzi (tebipenem pivoxil) as the first and only oral carbapenem antibiotic for adults with complicated urinary tract infections, including pyelonephritisi, caused by certain susceptible pathogens in patients with limited or no alternative oral treatment options.
The decision follows a previous FDA Complete Response Letter (CRL) issued in June 2022, when the agency determined that additional data were needed to support the approval while the program was still under Spero Therapeutics' ownership. After GSK entered into an exclusive licensing agreement with Spero later that year, the companies resubmitted the NDA in December 2025, supported...