FDA Extends New Approval to UTI Medication

April 25, 2024
The medication, called Pivya, is approved for use in adult females.

The FDA has approved a medication called Pivya (pivmecillinam), a tablet for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.

Uncomplicated UTIs are “bacterial infections of the bladder in females with no structural abnormalities of their urinary tract. Approximately one-half of all women experience at least one UTI in their lifetime.”

Pivya was tested in females 18 years of age or older in three controlled clinical trials “comparing different…dosing regimens to placebo, to another oral antibacterial drug, and to ibuprofen.” The primary measure of efficacy, the “composite response rate” including clinical care and microbiological response, was assessed 8 to 14 days after patients enrolled in the studies. Compared to a placebo, patients receiving Pivya “achieved the composite response” at a 62% rate compared to 10% of the patients who received the placebo; 72% of patients receiving Pivya achieved composite response to 76% of the patients receiving the oral antibacterial comparator drug; and 66% of patients receiving Pivya achieved composite response compared to 22% of those who received ibuprofen.