FDA Approves Utility Therapeutics’ Pivya to Treat Uncomplicated Urinary Tract Infections in Adult Females

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The FDA announced that it has approved Pivya (pivmecillinam), for the treatment of uncomplicated urinary tract infections (UTIs) in adult females. According to the agency, the approval supports a communal health issue, with close to half of all women experiencing at least one UTI in their lifetime. Before reaching approval, Pivya, which is now available, was given Priority Review and Qualified Infectious Disease Product designations. As part of its support against UTIs, Pivya was designed to fight specific bacteria strains such as Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.

The FDA based their approval on positive results from three different clinical trials comparing various Pivya dosing regimens to placebo, a different oral antibacterial drug, and ibuprofen. In all three trials, Pivya demonstrated a higher level of effectiveness in treating UTIs than the previously mentioned treatments, with substantial symptom resolution and bacterial reduction. Anywhere from 8 to 14 days after enrollment, the investigators found that 62% of patients administered Pivya achieved a composite response compared to 10% who received a placebo. When comparing the treatment to another antibacterial drug, 72% of patients administered Pivya achieved the composite response compared to 76% for the other treatment. Further 66% of 105 subjects administered Pivya achieved composite response compared to 22% of 119 individuals who received ibuprofen.

In terms of safety, common adverse effects included nausea and diarrhea.¹

“Uncomplicated UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use,” said Peter Kim, MD, MS, director, division of anti-infectives, center for drug evaluation and research, FDA, in a press release. “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.”

According to Medscape, common symptoms of UTIs include urinary urgency, bloody urine, a feeling of bladder fullness, lower abdominal discomfort, costovertebral angle tenderness, fevers, chills, and dysuria. Currently, diagnosis relies on dipstick, urinalysis, and culture.²

“Urinary tract infections (UTIs) occur far more commonly in women, accounting for at least 8 million visits to various types of healthcare facilities in the United States per year. Cystitis (bladder infection) represents most of these infections,” reports Medscape. “20% of women suffer from at least one UTI in their lifetime. Related terms include pyelonephritis, which refers to upper UTI, and bacteriuria or funguria, which describe findings of bacteria or yeast, respectively, in the urine.”

Current treatments for UTIs include antibiotics such as cephalexin, ceftriaxone, trimethoprim and sulfamethoxazole, fosfomycin, and nitrofurantoin.³

“Antibiotics usually are the first treatment for urinary tract infections,” reports the Mayo Clinic. “Your health and the type of bacteria found in your urine determine which medicine is used and how long you need to take it.”

The FDA warns against the use of Pivya in patients who have past issues with severe hypersensitivity to beta-lactam antibacterial drugs, a primary or secondary carnitine deficiency resulting from inherited disorders of mitochondrial fatty acid oxidation and carnitine metabolism, or porphyria.¹

References

1. FDA Approves New Treatment for Uncomplicated Urinary Tract Infections.FDA. April 24, 2024. Accessed April 25, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-uncomplicated-urinary-tract-infections?utm_medium=email&utm_source=govdelivery

2. Urinary Tract Infection (UTI) and Cystitis (Bladder Infection) in Females. Medscape. January 26, 2023. Accessed April 25, 2024. https://emedicine.medscape.com/article/233101-overview#:~:text=United%20States%20statistics,those%20visits%20are%20to%20EDs.

3. Urinary tract infection (UTI). Mayo Clinic. Accessed April 25, 2024. https://www.mayoclinic.org/diseases-conditions/urinary-tract-infection/diagnosis-treatment/drc-20353453