First new antibiotic for urinary tract infections approved in 20 years to help millions of women who don’t respond to other medications
- The FDA has approved the drug pivmecillinam for “uncomplicated” urinary tract infections
- It will be sold in America under the Pivya brand from sometime in 2025
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A new pill for urinary tract infections has been approved for the first time in two decades in the hope of combating bugs that are resistant to antibiotics.
The FDA has approved the drug pivmecillinam — sold under the brand name Pivya — for “uncomplicated” urinary tract infections, meaning the infection is in 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 will be available by prescription next year for millions of American women over 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 in the US as Pivya – for “uncomplicated” urinary tract infections, meaning the infection is in the bladder and has not spread to the kidneys.
“Uncomplicated urinary tract infections are a common condition affecting women and one of the most common reasons for antibiotic use,” said Dr. Peter Kim, director of the Anti-Infectives Division of the FDA’s Center for Drug Evaluation and Research.
“The FDA is committed to advancing the availability of new antibiotics when they are proven to be safe and effective.”
It’s the first time in two decades that the FDA has approved a new antibiotic for urinary tract infections, which affect 30 million Americans annually.
Antibiotic resistance is a growing problem, as pathogens adapt to resist powerful drugs intended to kill them.
According to the newspaper, the problem is linked to almost five million deaths World Health Organisation.
The majority of urinary tract infections 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 their urine.
Although men can contract urinary tract infections, the problem affects women more often. More than half of women in the U.S. will develop a urinary tract infection at some point in their lives, compared to just 14 percent of men.
This is because women have shorter urethras than men, which means bacteria can reach the urinary tract more easily.
About a quarter of women experience recurrent urinary tract infections, which is defined as at least two infections in six months, or three in a year.
Most urinary tract infections are now resistant to at least one antibiotic. Ampicillin, once a common treatment, is now rarely used.
Studies have shown that more than 92 percent of bacteria that cause a urinary tract infection are resistant to at least one common antibiotic, and nearly 80 percent are resistant to at least two antibiotics.
Once infections have reached the kidneys or enter the bloodstream, they are 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 are rare.
The most common side effects of pivmecillinam in clinical trials were nausea and diarrhea, the FDA said.
Dr. Shruti Gohil, professor of infectious diseases at the University of California, Irvine School of Medicine, said The New York Times pivmecillinam represented an ‘exciting new option for the treatment of lower urinary tract infections.’
“But I would also say that it is going to be important that we use the drug responsibly in this country so that we don’t develop resistance to it.”