FDA Greenlights Pivya, a Novel Option for Uncomplicated Urinary Tract Infections

April 24, 2024 – The U.S. Food and Drug Administration (FDA) has announced the approval of a new medication, Pivya (pivmecillinam) tablets, offering fresh hope to adult women battling uncomplicated urinary tract infections (UTIs). This approval introduces an alternative treatment specifically targeting UTIs caused by certain bacteria, including Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.

Dr. Peter Kim, M.D., M.S., the head of the Division of Anti-Infectives at the FDA’s Center for Drug Evaluation and Research, highlighted the significance of the approval, pointing out the frequent occurrence of uncomplicated UTIs among women and their substantial contribution to antibiotic consumption.

Uncomplicated UTIs, which are bacterial infections of the bladder in females without structural urinary tract abnormalities, can affect about 50% of all women at some point in their lives.

The FDA based Pivya's approval on evidence from three robust clinical trials. These studies pitted Pivya against placebo and standard treatments, including another oral antibacterial drug and the anti-inflammatory drug, ibuprofen. The trials were measured by the composite response rate, focusing on both the clinical cure - the resolution of initial symptoms without new ones - and the microbiological response, defined by a significant decrease in the urine-cultured bacteria.

The standout result from the trial comparing Pivya to placebo showed that 62% of participants treated with Pivya experienced favorable composite responses, whereas only 10% of placebo recipients did. Moreover, Pivya went head-to-head with another antibacterial drug, resulting in a similar effectiveness rate, and when compared with ibuprofen, Pivya treatment saw a higher rate of composite response (66% vs. 22%).

As with any medication, Pivya comes with its precautionary advice due to potential side effects, the most common being nausea and diarrhea. Concerns are also in place for patients with severe hypersensitivity to Pivya or other beta-lactam antibacterial drugs, those with inherited disorders affecting carnitine metabolism, and individuals with porphyria.

Besides, Pivya includes warnings regarding hypersensitivity reactions, severe skin reactions, carnitine depletion, C. difficile-associated diarrhea, and possible interference with screening for a rare metabolic disorder in newborns.

The introduction of Pivya onto the pharmaceutical market was expedited by its Priority Review and Qualified Infectious Disease Product designations, speaking to the urgency and necessity of advancing effective UTI treatments. UTILITY therapeutics Ltd is the company trusted with the production and distribution of Pivya following its FDA endorsement.

For further information and the original announcement from the FDA, readers can click on the following link: FDA Approves New Treatment for Uncomplicated Urinary Tract Infections.

The FDA, part of the U.S. Department of Health and Human Services, continues its mission to safeguard public health through rigorous regulation of drugs, vaccines, medical devices, food supply, cosmetics, and more.

For press inquiries, contact Chanapa Tantibanchachai at chanapa.tantibanchachai@fda.hhs.gov or call 202-384-2219. Consumers can reach out to the FDA at 888-INFO-FDA.

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