Pivya Approved for Uncomplicated UTIs

FDA has approved Utility Therapeutics’ Pivya (pivmecillinam) tablets to treat female adults with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus. An agency announcement says Pivya’s efficacy for its indication was assessed in three trials comparing different dosing regimens to placebo, another oral antibacterial drug, and ibuprofen.

The most common side effects included nausea and diarrhea, the announcement says. The labeling has Warnings and Precautions such as hypersensitivity reactions, severe cutaneous adverse reactions, carnitine depletion, Clostridioides difficile-associated diarrhea, and interference with a newborn screening test for isovaleric acidemia.

Pivya was granted priority review and qualified infectious disease product designations for this indication.