FDA approves Utility Therapeutics’ Pivya tablets for UTIs

25 Apr 2024
www.pharmaceutical-technology.com
Priority ReviewDrug ApprovalClinical ResultQualified Infectious Disease ProductPhase 3
Pivya is intended for treating UTIs. Credit: ANN PATCHANAN via Shutterstock.
PivyaS Food and Drug AdministraUTIs (FDA) has approved Utility Therapeutics’ Pivya tablets, a new treatment for female adults with uncomplicated urinary tract infections (UTIs).
This deFood and Drug Administration (FDA) Pivya in treaUtility TherapeuticssuPivyaible Escherichia coli isolates, Staphylococcus sauncomplicated urinary tract infections (UTIs)
The approval was supported by three controPivyaclinical triaUTIsThese trials assessed the efficacy of Pivya in treating females aged 18 years or older with uncomplicated UTIs, comparing various dosing regimens of the drug to placebo, another oral antibacterial drug, and to anti-inflammatory drug ibuprofen.
The trials’ primary efficacy measure was the composite response rate, which included both clinical curPivya microbiological response.uncomplicated UTIsibuprofen
In the study comparing Pivya to placebo, 62% of the 137 participants receiving the therapy achieved the composite response, significantly higher than the 10% response rate in the placebo group.
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When compared to another oral antibacterial drug, Pivya’s composite response rate was 72%, closely matching the comparator drug’s 76%. Against ibuprofen, Pivya showed a 66% response rate, compared to 22% for those who received the anti-inflammatory drug.
Novartisnd diarrhoea were the common side effectsLutathera during the trials for Pivya.
The FDA advises against the use of Pivya in patients with a history of severe hypersensitivity to beta-lactam antibacterial drugs, those with carnitine deficiency disorders, and individuals suffering from porphyria.
Pivya carries warnings for potential hypersensitivPivyaeactions, carnitine depletion, severe cutaneous adverse reactions, Clostridioides difficibuprofeniaPivyaiarrhoea, and possible interference with newborn screening tests for metabolic disorder isovaleric acidemia.
NauseaA gradiarrhoeaa priority review and qualified infectious disease product designations.
FDA FDAter for Drug Evaluation and Pivyarch Anti-Infectives division director hypersensitivity“Uncomplicated UTIs are a very common condition carnitine deficiency disorders most frequent reasons for antibiporphyria
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