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FDA has approved intravenous fosfomycin for the treatment of cUTI
FDA has approved intravenous fosfomycin for the treatment of cUTI
On October 22, 2025, the U.S. Food and Drug Administration (FDA) approved intravenous fosfomycin for the treatment of complicated urinary tract infections (cUTI).
Laboratorios ERN expresses its satisfaction with the recent approval by the U.S. Food and Drug Administration (FDA) of intravenous fosfomycin for the treatment of patients aged 18 years and older with complicated urinary tract infection (cUTI), including acute pyelonephritis.
This milestone represents a significant advancement in access to innovative therapeutic options for adult patients with complicated urinary tract infections, now also in the United States.
It is worth noting that Laboratorios ERN played a key role as the U.S. sponsor for the introduction of this molecule before transferring the rights to Meitheal Pharmaceuticals, which becomes a strategic partner for its commercialization in the coming years.
The FDA approval was based on data from the ZEUS study, a multinational, double-blind clinical trial that included 464 hospitalized adults with complicated urinary tract infection, including acute pyelonephritis. This study compared fosfomycin 6 grams administered intravenously every 8 hours with piperacillin/tazobactam 4.5 grams administered intravenously every 8 hours for 7 days of treatment, allowing a maximum of 14 days in patients with bacteremia.
Intravenous fosfomycin demonstrated its efficacy with an overall success rate — defined as clinical cure plus microbiological eradication — in 63.5% of treated patients, compared to 55.6% in those treated with piperacillin/tazobactam.
In conclusion, intravenous fosfomycin is considered an intravenous therapeutic option with a differentiated mechanism of action for patients with severe infections caused by Enterobacterales. Laboratorios ERN wishes to convey its best wishes to the Meitheal Pharmaceuticals team for the successful future launch of this medicine.
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