FDA Approves New Antibiotic for Common Urinary Tract Infections

Pivya is the first new antibiotic for UTIs in 20 years

A sign for the Food and Drug Administration (FDA) outside of the headquarters in White Oak, Md., on July 20, 2020. Sarah Silbiger/Getty Images

Urinary tract infections, once routinely cured with antibiotics, are becoming a stubbornly difficult foe as the infections grow increasingly resistant to front-line drugs.

But now, women battling common UTIs have a new treatment option after the U.S. Food and Drug Administration approved the first new antibiotic for these infections in 20 years. The drug, pivmecillinam, will help fight an ailment that accounts for over 8 million doctor visits annually in the U.S. alone.

Frequently Prescribed Abroad

While new to the U.S., pivmecillinam boasts over four decades of use across Europe as a front-line treatment option for uncomplicated UTIs in women. Uncomplicated UTIs refer to infections localized to the bladder that haven’t spread to the kidneys.

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

In the U.S., the drug will be marketed as Pivya and will only be available by prescription for women aged 18 and older. Utility Therapeutics Ltd. has acquired the rights to pivmecillinam and is responsible for bringing this treatment to the U.S. market, according to the company’s website.

Pivya Outperforms Placebo, Ibuprofen in Trials

Pivya’s approval followed three controlled clinical trials evaluating its efficacy against a placebo, another oral antibacterial drug, and ibuprofen. These trials measured composite response rate—the percentage of patients who experienced a reduction in their UTI symptoms—between eight and 14 days after enrollment.

In the placebo-controlled trial, 62 percent of 137 Pivya patients achieved composite response compared to only 10 percent of 134 placebo patients.

When compared to another oral antibacterial, 72 percent of 127 Pivya patients responded favorably versus 76 percent of 132 patients on the other drug.

Against ibuprofen, 66 percent of 105 Pivya patients achieved composite response, significantly higher than 22 percent of 119 ibuprofen patients.

“Pivya will provide an additional treatment option for uncomplicated UTIs,” Dr. Kim said.

Possible Side Effects

Pivya is not without side effects.

The most common are nausea and diarrhea, but it can also cause hypersensitivity reactions, carnitine depletion, severe skin reactions, and interference with newborn screening for isovaleric acidemia, a rare metabolic disorder that causes buildup of harmful substances in the body.

The FDA cautions against Pivya for those with severe hypersensitivity to beta-lactam antibiotics, primary/secondary carnitine deficiencies from fatty acid oxidation/metabolism disorders, and people with porphyria, which is a type of disorders that can cause nerve or skin problems.

UTIs affect a significant portion of the population, with 60 percent of women and 12 percent of men experiencing at least one in their lifetime, according to the American Medical Association. These infections occur when bacteria enter the urethra and are more prevalent in women due to their shorter urethras. Typical UTI symptoms include an irritated, painful bladder and urethra, lower abdominal and pelvic pain, and a frequent, burning urge to urinate despite little urine in the bladder.