The approval was based on results from three controlled clinical trials of females aged 18 and above in which Pivya achieved the primary efficacy measure
FDA approves Pivya tablets for urinary tract infections. (Credit: Michal Jarmoluk from Pixabay)
The US Food and Drug Administration (FDA) has authorised the use of Utility Therapeutics’ Pivya (pivmecillinam) tablets in female adults with uncomplicated urinary tract infections (UTIs).
For this indication, Pivya had earlier received priority review and qualified infectious disease product designations.
Its approval was based on results from three controlled clinical trials of females aged 18 and above.
It assessed the efficacy of Pivya in treating uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli isolates, Staphylococcus saprophyticus, and Proteus mirabilis.
The trials compared various dosing regimens of Pivya to placebo, another oral antibacterial drug, and to anti-inflammatory drug ibuprofen.
The primary efficacy measure across the trials was the composite response rate, which combined clinical cure and microbiological response.
The composite response rate was assessed approximately eight to 14 days after patients were enrolled.
In the trial comparing Pivya tablets to placebo, 62% of the 137 Pivya recipients achieved the composite response compared to 10% of the 134 placebo-receiving individuals.
The trial comparing Pivya to another oral antibacterial drug revealed that 72% of the 127 Pivya recipients achieved the composite response, compared to 76% of the 132 recipients of the comparator drug.
Against ibuprofen, 66% of the 105 Pivya recipients achieved the composite response against 22% of the 119 ibuprofen recipients.
The common side effects reported during these trials were nausea and diarrhoea.
FDA Center for Drug Evaluation and Research anti-infectives division director Peter Kim said: “Uncomplicated UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use.
“The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Pivya will provide an additional treatment option for uncomplicated UTIs.”