FDA approves pivmecillinam tablets for uncomplicated UTIs

The approval follows a priority review designation to a new drug application for pivmecillinam in January 2024.

The FDA has approved oral pivmecillinam (Pivya) tablets for the treatment of adult female patients with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.¹

“Uncomplicated UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use. 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,” said Peter Kim, MD, MS, in a news release from the FDA.¹ Kim is the director of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research.

The approval of the antibiotic is based on data from 3 clinical trials evaluating the efficacy of different pivmecillinam dosing regimens in comparison with either placebo, another oral antibacterial drug, or ibuprofen. These studies all enrolled adult female patients with uncomplicated UTIs.

The primary end point for these trials was the composite response rate, as measure by clinical cure (the resolution of uncomplicated UTI symptoms that were present at baseline and no new symptoms) and microbiological response (a reduction in the bacteria cultured from patients’ urine at baseline). Composite response was assessed in patients at approximately 8 to 14 days from study entry.

In the clinical trial of pivmecillinam vs placebo, a composite response was achieved in 62% of patients who received pivmecillinam (n = 137) compared with 10% of patients who received placebo (n = 134). In the study of pivmecillinam vs another oral antibacterial drug, a composite response was achieved in 72% of patients who received pivmecillinam (n = 127) compared with 76% of patients who received the comparator drug (n = 132). Additionally, in the trial comparing pivmecillinam with placebo, a composite response was achieved in 66% of patients who received pivmecillinam (n = 105) vs 22% of patients who received ibuprofen (n = 119).²

Regarding safety, the most common adverse events associated with pivmecillinam included nausea and diarrhea.

Pivmecillinam is an aminopenicillin, a specific class of beta-lactam antibiotics, and is administered via oral tablets.³ Utility Therapeutics, the developer of the therapy, also offers mecillinam via intravenous administration.

According to the company, pivmecillinam (oral) is recommended by the Infectious Diseases Society of America for the first-line treatment of uncomplicated UTIs.

The approval of the therapy follows a decision by the FDA to grant priority review to the new drug application for pivmecillinam in January 2024.⁴ The therapy was also awarded Qualified Infectious Disease Product Designation in 2018, granting it 5 additional years of data exclusivity upon approval.

References

1. FDA approves new treatment for uncomplicated urinary tract infections. News release. U.S. Food & Drug Administration. Published online and accessed April 24, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-uncomplicated-urinary-tract-infections

2. Ibuprofen versus mecillinam for uncomplicated systitis (IMUTI). ClinicalTrials.gov. Last updated November 6, 2017. Accessed April 24, 2024. https://clinicaltrials.gov/study/NCT01849926

3. Product Pipeline. Utility Therapeutics. https://utilitytherapeutics.com/our-focus/#product-pipeline

4. UTILITY therapeutics Ltd. announces financing led by the AMR Action Fund and FDA acceptance of PIVYA New Drug Application with priority review. News release. Utility Therapeutics. January 17, 2024. Accessed April 24, 2024. https://finance.yahoo.com/news/utility-therapeutics-ltd-announces-financing-110000751.html