The Food and Drug Administration on Wednesday approved the sale of an antibiotic for the treatment of urinary tract infections in women, giving American health providers a powerful new tool to combat a common infection that is increasingly unresponsive to the existing set. of antimicrobial drugs.
The drug, pivmecillinam, has been used in Europe for more than 40 years, where it is typically a first-line therapy for women with uncomplicated UTIs, meaning the infection is limited to the bladder and has not reached the kidneys. The drug will be marketed in the United States as Pivya and will be available by prescription for women over 18 years of age.
It is the first time in two decades that the FDA has approved a new antibiotic for urinary tract infections, which affect 30 million Americans annually. Urinary infections are responsible for the increased use of antibiotics outside the hospital setting.
“Uncomplicated urinary tract infections are a very common condition affecting women and one of the most frequent reasons for the use of antibiotics,” Dr. Peter Kim, director of the Division of Antiinfectives at the Evaluation Center, said in a statement. and FDA Drug Research. “The FDA is committed to promoting the availability of new antibiotics when they are proven to be safe and effective.”
Utility Therapeutics, the US company that acquired the rights to pivmecillinam, said it would be available in 2025. The company is also seeking FDA approval for an intravenous version of the drug that is used for more serious infections and is usually administered in a setting hospitable. .
Health professionals said they were delighted to have another tool in their arsenal given the growing challenge of antimicrobial resistance, which makes existing drugs less effective as pathogens mutate in ways that allow them to survive a antibiotic treatment.
The problem, largely a consequence of overuse of antibiotics worldwide, is associated with five million deaths, according to the World Health Organization.
“This is an exciting new possibility for the treatment of lower urinary tract infections,” said Dr. Shruti Gohil, a professor of infectious diseases at the University of California, Irvine School of Medicine and author of a recent study in JAMA that focused on Ways to Reduce Overuse of Antibiotics in Hospitals. “But I would also say that it will be important that we use the drug responsibly in this country so that we don’t create resistance to it.”
Most urinary tract infections occur when bacteria such as E. coli travel from the rectum, genital area, or vagina to the urethra and enter the bladder. As they multiply, the pathogens can cause abdominal cramps, burning, and bloody urine.
More than half of all women in the United States will suffer from a UTI during their lifetime, compared to 14 percent of men. This is largely due to the different architecture of the urinary tract between the two sexes: women have shorter urethras than men, which makes it easier for bacteria to reach the urinary tract.
Most UTIs are now resistant to one or more antibiotics; Ampicillin, once a common treatment, has largely been abandoned. Infections that travel to the kidneys or enter the bloodstream are harder to treat and more dangerous.
People with weakened immune systems or chronic medical conditions are often the most vulnerable to drug-resistant infections. But UTIs have a dubious distinction: They are the biggest risk to healthy people due to drug-resistant germs.
In the four decades since it was first approved for use in Europe, pivmecillinam has been prescribed more than 30 million times, mainly in the Nordic countries, and few complications have been reported.
The FDA said nausea and diarrhea were the most common side effects in the clinical trials that paved the way for pivmecillinam’s approval in the United States.
Tom Hadley, president and chief operating officer of Utility Therapeutics, said his company moved to acquire the U.S. rights to pivmecillinam after Congress in 2012 granted an additional five years of exclusivity to makers of new antimicrobial drugs.
Henry Skinner, CEO of AMR Action Fund, a venture capital fund that invested in Utility Therapeutics’ bid to bring pivmecillinam to the U.S., said he was pleased with the FDA approval but said the outlook long term for new antimicrobial drugs remained. severe. The $1 billion fund, funded by the pharmaceutical industry, invests in biotech startups working on promising antimicrobials.
Most of the country’s largest drugmakers, unable to turn a profit on antibiotics, have long since abandoned the field, he said, and a lack of investment has led to an exodus of talented researchers.
A federal initiative that would create a subscription-based model for antibiotic development has been languishing in Congress. The $6 billion measure, the Pasteur Act, would provide pharmaceutical companies with an upfront payment in exchange for unlimited access to a drug once it is approved by the FDA.
Skinner said he was haunted by a recent estimate suggesting drug-resistant infections could claim 10 million lives by 2050.
“There are definitely positives,” he said. “But more people are dying today than they should because we are going backwards and failing to provide the doctors, medications and diagnostics needed to address the antimicrobial resistance crisis.”
