FDA greenlights antibiotic Pivya for uncomplicated UTIs

24 Apr 2024
firstwordpharma.com
Clinical ResultPriority ReviewDrug ApprovalPhase 3
The FDA on Wednesday approved UTILITY therapeutics' oral antibiotic Pivya (pivmecillinam) as a new treatment option for adult females with uncomplicated urinary tract infections (UTIs) caused by specific bacterial strains.
The company says its treatment, already approved in Europe, targets PBP-2 in the cell wall of Gram-negative bacteria and has a unique mechanism of action that leads to favourable stability against beta-lactamase hydrolysis compared to other penicillins.
The US filing, which had been granted a priority review, was based on efficacy data across three controlled trials comparing various Pivya dosing regimens to placebo, an existing oral antibiotic, and the anti-inflammatory ibuprofen.
The primary endpoint measured a composite response rate that included clinical cure and microbiological reduction of the causative bacteria. Clinical cure was defined as resolution of the uncomplicated UTI symptoms that were present in patients at trial entry and no new symptoms. The composite response rate was assessed about 8 to 14 days after patients were enrolled.
In the placebo-controlled study, 62% of Pivya recipients achieved the composite response versus 10% on placebo. Against the approved antibiotic comparator, response rates were 72% and 76%, respectively. In the third trial, 66% of those who received Pivya achieved composite response compared to 22% with ibuprofen.
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