The FDA has approved a new treatment for uncomplicated urinary tract infections in women caused by bacteria including Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.
"Uncomplicated UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use. The approval of Pivya [pivmecillinam] introduces an additional, effective treatment option for this debilitating condition," said Peter Kim, M.D., M.S., director of the Division of Anti-Infectives at the FDA's Center for Drug Evaluation and Research.
Urinary tract infections (UTIs) typically affect the bladder and occur without structural abnormalities in the urinary tract. Statistically, one out of every two women will experience a UTI in her lifetime.
Pivya's journey to approval was tested through three controlled clinical trials, which compared various dosing regimens of Pivya against a placebo, another oral antibacterial drug, and ibuprofen, according to the FDA's news release.
In a study comparing Pivya to a placebo, 62% of the 137 women treated with Pivya showed a composite response rate—defined as both the clinical cure of symptoms and a microbiological response—compared to only 10% of those on the placebo. Similarly, in trials against another antibacterial and ibuprofen, Pivya demonstrated comparable and superior efficacy, respectively.
Despite its effectiveness, Pivya is not suitable for everyone, noted the FDA. It should not be used by patients with severe hypersensitivity to Pivya or other beta-lactam antibacterial drugs, nor by those with certain metabolic disorders such as primary or secondary carnitine deficiency or porphyria. Common side effects include nausea and diarrhea, and there are significant warnings about potential hypersensitivity reactions, severe cutaneous adverse reactions, carnitine depletion, Clostridioides difficile-associated diarrhea, and possible interference with newborn screening tests for rare metabolic disorders.
The approval of Pivya not only promises to improve quality of life for many women but also represents a critical step forward in the ongoing effort to enhance antibiotic treatment regimens, according to the FDA.