Becker's Healthcare April 25, 2024
The FDA approved the first new antibiotic for urinary tract infections in two decades.
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...
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