- The FDA has approved the drug pivmecillinam for “uncomplicated” UTIs.
- It will be sold under the Pivya brand in America starting in 2025
- READ MORE: Victims of ‘killer’ antibiotic: 44-year-old mother suffers stroke
For the first time in two decades, a new pill has been approved for urinary tract infections in hopes of combating antibiotic-resistant bugs.
The FDA has approved the drug pivmecillinam, sold under the brand name Pivya, for “uncomplicated” UTIs, meaning the infection is contained to the bladder and has not spread to the kidneys.
It has been used as a first-line treatment in Europe for more than 40 years, but next year it will be available by prescription to millions of American women over the age of 18.
Utility Therapeutics, the company developing the drug, is also seeking approval for an intravenous version given in the hospital for more serious infections.
The FDA has approved the drug pivmecillinam, sold as Pivya in the United States, for single “uncomplicated” infections, meaning the infection is contained to the bladder and has not spread to the kidneys.
“Uncomplicated UTIs are a very common condition affecting women and one of the most common reasons for antibiotic use,” said Dr. Peter Kim, director of the Evaluation Center’s Division of Antiinfectives and FDA Drug Research.
“The FDA is committed to encouraging the availability of new antibiotics when they prove safe and effective.”
It is the first time in 20 years that the FDA has approved a new antibiotic for UTIs, which affect 30 million Americans each year.
Antibiotic resistance is a growing problem, when pathogens adapt in ways that allow them to resist powerful drugs designed to kill them.
The problem is associated with nearly five million deaths, according to the World Health Organization.
Most UTIs occur when bacteria such as E.coli travel from the rectum, genital area, or vagina to the urethra and bladder.
As the bacteria multiply, patients may experience abdominal cramps, burning sensations, and blood in the urine.
Although men can get UTIs, the problem overwhelmingly affects women more often. More than half of women in the US will have a UTI at some point in their lives, compared to just 14% of men.
This is because women have shorter urethras than men, which means it is easier for bacteria to reach the urinary tract.
Around a quarter of women suffer from recurrent UTIs, which are defined as at least two infections in six months, or three in a year.
Most UTIs are resistant to at least one antibiotic. Ampicillin, once a common treatment, is now rarely used.
Studies have shown that more than 92 percent of the bacteria that cause a UTI are resistant to at least one common antibiotic, and about 80 percent are resistant to at least two.
If the infections have reached the kidneys or go into the bloodstream, this makes them more difficult to treat.
Pivmecillinam has been prescribed more than 30 million times in Europe, with most use in the Nordic countries, and reports of complications have been rare.
The most common side effects of pivmecillinam in clinical trials were nausea and diarrhea, the FDA said.
Dr. Shruti Gohil, a professor of infectious diseases at the University of California, Irvine School of Medicine, told the New York Times that pivmecillinam represented an “exciting new possibility for the treatment of lower urinary tract infections.” .
“But I would also say that it will be important that we use the drug responsibly in this country so that we don’t build resistance against it.”
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