FDA approves new treatment for uncomplicated UTIs

The US Food and Drug Administration (FDA) yesterday announced the approval of Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.

The FDA granted the approval of Pivya to Utility Therapeutics, privately-held UK-based biotechnology, which already has approval of the drug in Europe for uncomplicated urinary tract infections (UTIs).

“Uncomplicated UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use,” said Dr Peter Kim, director of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research, adding: “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.”