The Food and Drug Administration on Wednesday approved the sale of an antibiotic to treat urinary tract infections in women, giving US health care providers a powerful new tool to fight a common infection that is increasingly unresponsive to the existing line of antimicrobial drugs.
The drug, pivmecillinam, has been used in Europe for more than 40 years, where it is often first-line treatment for women with uncomplicated UTIs, meaning the infection is confined to the bladder and has not reached the kidneys. The drug will be marketed in the US as Pivya and will be available by prescription to women 18 and older.
It is the first time in two decades that the FDA has approved a new antibiotic for UTIs, which affect 30 million Americans annually. UTIs are responsible for the most out-of-hospital use of antibiotics.
“Uncomplicated UTIs are a very common condition affecting women and one of the most common reasons for antibiotic use,” said Dr. he said in a statement. “The FDA is committed to encouraging the availability of new antibiotics when they are proven to be safe and effective.”
Utility Therapeuticsthe 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 used for more serious infections and usually given in a hospital setting.
Health professionals said they were 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 a result of overuse of antibiotics worldwide, is linked to five million deaths, according to World Health Organisation.
“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’s going to be important to use the drug responsibly in this country so that we don’t build resistance against it.”
Most UTIs 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 women in the United States will get a UTI in their lifetime, compared to 14 percent of men. This is largely due to the different architecture of the urinary system in the two sexes: Women have a smaller urethra than men, which makes it easier for bacteria to reach the urinary system.
The majority of UTIs are now resistant to one or more antibiotics. Ampicillin, once a common treatment, has been largely abandoned. 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 conditions are usually the most vulnerable to drug-resistant infections. But UTIs have a dubious distinction: They are the single greatest risk to healthy people from 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, mostly in Nordic countries, with few reported complications.
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, chairman and CEO of Utility Therapeutics, said his company moved to acquire the US rights to pivmecillinam after Congress in 2012 granted an additional five years of exclusivity to makers of new antimicrobial drugs.
Henry Skinner, managing director at the AMR Action Fund, a venture capital fund that invested in Utility Therapeutics’ effort to bring pivmecillinam to the US, said he was pleased with the FDA’s approval but said the long-term outlook for new antimicrobials remains bleak. The $1 billion fund, funded by the pharmaceutical industry, invests in biotech startups working on promising antimicrobials.
Most of the country’s biggest drugmakers, unable to make a profit on antibiotics, have long since left the field, he said, and a lack of investment has caused talented researchers to flee.
A federal initiative that would create a subscription-based model for antibiotic development is languishing in Congress. The $6 billion measure, the Pasteur’s lawwould provide pharmaceutical companies with an upfront payment in exchange for unrestricted access to a drug once approved by the FDA
Mr Skinner said it haunted him a recent estimate suggesting that drug-resistant infections could claim 10 million lives by 2050.
“There are definitely bright spots,” he said. “But more people are dying today than should be because we are going backwards and not providing the doctors, drugs and diagnostics needed to address the antimicrobial resistance crisis.”