FDA Approves Antibiotic for Increasingly Hard-to-Treat Urinary Tract Infections

Pivmecillinam, used in Europe for decades, will be available next year for women 18 and older.

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 fight an infection common that is increasingly unresponsive to the existing suite of antimicrobial drugs.

The drug, pivmecillinam, has been used in Europe for more than 40 years, where it is often a first-line treatment for women with uncomplicated urinary tract infections. , which means that the infection is limited to the bladder and has not reached the kidneys. The drug will be marketed in the United States under the name Pivya and will be available by prescription for women 18 years and older.

This is the first time in two decades that the F.D.A. 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 of the hospital setting.

“Uncomplicated urinary tract infections are a very common condition among women and men. one of the most common reasons for resorting to antibiotics. use,” Dr. Peter Kim, director of the Division of Antiinfectives at the FDA’s Center for Drug Evaluation and Research, said in a statement. “The FDA. is committed to promoting the availability of new antibiotics when they prove safe and effective. in 2025. The company is also seeking the FDA. approval of an intravenous version of the drug which is used for more serious infections and is usually administered in a hospital setting.

Healthcare practitioners said they were pleased 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.

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