FDA approves antibiotic for increasingly difficult-to-treat urinary tract infections

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 series of antimicrobial drugs.

The drug, pivmecillinam, has been used in Europe for more than 40 years, where it is often first-line therapy for women with uncomplicated single infections, meaning the infection is confined to the bladder and has not reached to the kidneys The drug will be marketed in the United States 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 largest use of antibiotics outside the hospital setting.

Uncomplicated yeast infections are a very common condition affecting women and one of the most common reasons for antibiotic use, Dr. Peter Kim, director of the Center’s Division of Antiinfectives, said in a statement. ‘FDA Drug Evaluation and Research. The FDA is committed to encouraging 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 will be available by 2025. The company is also seeking FDA approval for an intravenous version of the drug used for more infections serious and which is usually administered in a hospital setting. .

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 course of antibiotics.

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, 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 the 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 as not to 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 urination.

More than half of women in the United States will acquire a UTI in their lifetime, compared to 14% of men. This is largely due to the different architecture of the urinary tract in the 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 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 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 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, president and chief operating officer of Utility Therapeutics, said his company moved to acquire the US rights to pivmecillinam after Congress in 2012 granted five additional years of exclusivity to the new manufacturers antimicrobial drugs.

Henry Skinner, chief executive of the AMR Action Fund, a venture capital fund that invested in Utility Therapeutics to bring pivmecillinam to the US, said he was pleased with the FDA’s approval, but said the outlook for long term of the new antimicrobial drugs remained dismal. . The $1 billion fund, funded by the pharmaceutical industry, invests in new biotech companies working on promising antimicrobials.

Most of the nations’ biggest drugmakers, unable to make a profit on antibiotics, have long since left 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 drug companies with an upfront payment in exchange for unlimited access to a drug once it is approved by the FDA.

Mr. Skinner said he was haunted by 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.