The Food and Drug Administration on Wednesday approved the sale of an antibiotic for the treatment of urinary tract infections in women, giving U.S. health care providers a powerful new tool to combat a common infection that is increasingly unresponsive to the existing range of antimicrobial medications.
The drug, pivmecillinam, has been used in Europe for more than 40 years, where it is often first-line treatment for women with uncomplicated urinary tract infections, meaning the infection is confined to the bladder and does not did not reach the kidneys. The drug will be marketed in the United States under the name Pivya and will be available by prescription for women 18 and older.
It’s the first time in two decades that the FDA has approved a new antibiotic for urinary infections, which affect 30 million Americans each year. Urinary tract infections account for the greatest use of antibiotics outside of the hospital setting.
“Uncomplicated urinary tract infections are a very common condition among women and one of the most common reasons for antibiotic use,” said Dr. Peter Kim, director of the Division of Anti-Infectives at the Center for Antibiotics. FDA Drug Evaluation and Research. said in a statement. “The FDA is committed to promoting the availability of new antibiotics when they are proven safe and effective. »
Therapeutic utilitythe US company that acquired the rights to pivmecillinam, said the product would be available in 2025. The company is also seeking FDA approval for an intravenous version of the drug, used to treat more serious infections and usually administered in a hospital environment.
Health care practitioners said they are excited 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 course of antibiotics.
The problem, largely due to the 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, professor of infectious diseases at the University of California, Irvine School of Medicine, and author of a recent study. in JAMA which focused on ways to reduce the overuse of antibiotics in hospitals. “But I would also say that it will be important that we use this drug responsibly in this country so that we don’t breed resistance.”
Most UTIs occur when bacteria like E. coli travel from the rectum, genital area, or vagina to the urethra and enter the bladder. As they multiply, pathogens can cause abdominal cramps, burning and bloody urination.
In the United States, more than half of women will get a UTI in their lifetime, compared to 14% of men. This is largely due to the different architecture of the urinary tract between sexes: women have a shorter urethra than men, which makes it easier for bacteria to reach the urinary tract.
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