The Food and Drug Administration on Wednesday approved the sale of an antibiotic to treat urinary tract infections in women, giving U.S. health care providers a chance to fight common infections for which existing classes of antibiotics are becoming increasingly ineffective. provided powerful new tools for
The drug pivmecillinam has been used in Europe for more than 40 years and is often used as first-line therapy for women with uncomplicated urinary tract infections (infection limited to the bladder and not reaching the kidneys). It has been. The drug will be sold in the United States as Pivya and will be available by prescription to women 18 and older.
This is the first time in 20 years that the FDA has approved a new antibiotic for urinary tract infections, which affect 30 million Americans each year. Urinary tract infections are responsible for the greatest use of antibiotics outside the hospital.
“Simple urinary tract infections are a very common condition affecting women and one of the most frequent reasons for antibiotic use,” said Peter, director of the Division of Anti-Infectious Diseases in the FDA's Center for Drug Evaluation and Research. Dr. Kim said in a statement. “FDA is committed to promoting the use of new antibiotics once they are proven safe and effective.”
Utility Therapeutics, the US company that acquired the rights to pivmecillinum, said it would be available in 2025. The company is also seeking FDA approval for an intravenous version of the drug, which is used for more serious infections and is typically given in hospitals. .
Healthcare workers said they were elated to have another tool, given the growing challenge of antibiotic resistance. Resistant bacteria cause existing drugs to become less effective as pathogens mutate to survive antibiotics.
According to the World Health Organization, the problem is largely a result of overuse of antibiotics around the world and is associated with 5 million deaths.
“This is an exciting new possibility in the treatment of lower urinary tract infections,” said Shruti Gohil, professor of infectious diseases at the University of California, Irvine and author of a recent study highlighted in JAMA. said the doctor. How to reduce antibiotic overuse in hospitals. “But I would also say that it will be important that we use this drug responsibly so that we don't create resistance to it in this country.”
Most urinary tract infections occur when bacteria, such as E. coli, travel from the rectum, genital area, or vagina to the urethra and invade the bladder. When the pathogen grows, it can cause abdominal cramps, burning sensation, and blood in the urine.
More than half of all women in the United States will have a urinary tract infection in their lifetime, compared to 14 percent of men. This is mainly due to differences in the structure of the urinary tract between men and women. Women have a shorter urethra than men, making it easier for bacteria to reach the urinary tract.
The majority of urinary tract infections are now resistant to one or more antibiotics. Ampicillin, once a common treatment, is now rarely used. Infections that travel to the kidneys or enter the bloodstream are more difficult to treat and more dangerous.
People with weakened immune systems or chronic medical conditions are usually the most vulnerable to drug-resistant infections. But urinary tract infections have a dubious distinction. Urinary tract infections are the greatest risk to healthy people from drug-resistant bacteria.
In the 40 years since it was first approved for use in Europe, pivmecillinum has been prescribed more than 30 million times, mainly in Nordic countries, with few reported complications.
The FDA said the most common side effects in the clinical trials that paved the way for pivmecillinam's approval in the United States were nausea and diarrhea.
Tom Hadley, president and chief operating officer of Utility Therapeutics, announced that his The company said it has moved to acquire the U.S. rights to pivmecillinum.
Henry Skinner, chief executive officer of AMR Action Fund, a venture capital fund that invested in Utility Therapeutics' efforts to bring pivmecillinum to the United States, said he was pleased with the FDA's approval, but that the new antibacterial He said the long-term prognosis for the drug still remains grim. This $1 billion fund, backed by the pharmaceutical industry, invests in biotech startups developing promising antibiotics.
He said most of the country's biggest pharmaceutical companies are unable to make a profit from antibiotics and have long ago exited the field, and a lack of investment is prompting an exodus of talented researchers. That's what it means.
Federal efforts to create a subscription-based model for antibiotic development have stalled in Congress. The Pasteur Act, a $6 billion bill, would provide upfront payments to drug companies in exchange for unrestricted access to FDA-approved drugs.
Skinner said he was troubled by recent estimates that drug-resistant infections could claim 10 million lives by 2050.
“There are certainly silver linings,” he said. “But today, more people are dying than necessary because we are falling backwards and failing to provide the doctors, drugs and diagnostics we need to address the antimicrobial resistance crisis.” Because there isn't.