The agency approved pivmecillinam tablets for adult women with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus, an April 24 FDA news release said.
The approval for Pivya was given to Utility Therapeutics, a U.S. company that acquired the rights to the drug. It is expected to become available in 2025.
In clinical trials, Pivya outperformed placebo (62% vs. 10%) and ibuprofen (66% vs. 22%) for achieving composite response and was comparable to another oral antibacterial drug (72% vs. 76%).
“This is an exciting new possibility for treatment of lower urinary tract infections,” Shruti Gohil, MD, a professor of infectious diseases at the University of California, Irvine School of Medicine, told The New York Times. “But I would also say that it is going to be important that we use the drug responsibly in this country so that we don’t breed resistance against it.”
Pivmecillinam has been used in Europe for more than 40 years and is often a first-line treatment for uncomplicated UTIs in women. The most common side effects were nausea and diarrhea.
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