The US Food and Drug Administration (FDA) has approved Utility Therapeutics’ Pivya tablets, a new treatment for female adults with uncomplicated urinary tract infections (UTIs).
This decision is based on the efficacy of Pivya in treating UTIs caused by susceptible Escherichia coli isolates, Staphylococcus saprophyticus and Proteus mirabilis.
The approval was supported by three controlled clinical trials. These trials assessed the efficacy of Pivya in treating females aged 18 years or older with uncomplicated UTIs, comparing various dosing regimens of the drug to placebo, another oral antibacterial drug, and to anti-inflammatory drug ibuprofen.
The trials’ primary efficacy measure was the composite response rate, which included both clinical cure and microbiological response.
In the study comparing Pivya to placebo, 62% of the 137 participants receiving the therapy achieved the composite response, significantly higher than the 10% response rate in the placebo group.
When compared to another oral antibacterial drug, Pivya's composite response rate was 72%, closely matching the comparator drug's 76%. Against ibuprofen, Pivya showed a 66% response rate, compared to 22% for those who received the anti-inflammatory drug.
Nausea and diarrhoea were the common side effects reported during the trials for Pivya.
The FDA advises against the use of Pivya in patients with a history of severe hypersensitivity to beta-lactam antibacterial drugs, those with carnitine deficiency disorders, and individuals suffering from porphyria.
Pivya carries warnings for potential hypersensitivity reactions, carnitine depletion, severe cutaneous adverse reactions, Clostridioides difficile-associated diarrhoea, and possible interference with newborn screening tests for metabolic disorder isovaleric acidemia.
The FDA granted Pivya priority review and qualified infectious disease product designations.
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.”
