The U.S. Food and Drug Administration has approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs).
The approval is for UTIs caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus. The most common side effects of Pivya include nausea and diarrhea, and the drug should not be used in individuals with hypersensitivity to Pivya or other beta-lactam antibacterial drugs.
The approval was based on data from three trials in which different Pivya dosing regimens were compared to placebo, another oral antibacterial drug, or ibuprofen in women (aged 18 years and older) with uncomplicated UTIs. Sixty-two percent of the 137 participants receiving Pivya achieved the composite response (clinical cure and microbiological response) compared with 10 percent of the 134 participants receiving placebo. Compared with another oral antibacterial drug, 72 percent of the 127 participants receiving Pivya achieved the composite response versus 76 percent of the 132 participants receiving the comparator drug. Finally, compared with 22 percent of the 119 participants receiving ibuprofen, 66 percent of the 105 participants receiving Pivya achieved the composite response.
“Uncomplicated UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use,” Peter Kim, M.D., from the FDA Center for Drug Evaluation and Research, said in a statement. “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.”
Approval of Pivya was granted to UTILITY Therapeutics.
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