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Pivmecillinam, which has been used in Europe for decades, will become available next year to 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 providers a powerful new tool to combat a common infection 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 therapy for women with uncomplicated U.T.I.’s, meaning the infection is confined to the bladder and has not reached the kidneys. The drug will be marketed in the U.S. as Pivya and will be made available by prescription to women 18 and older.
It is the first time in two decades that the F.D.A. has approved a new antibiotic for U.T.I.s, which annually affect 30 million Americans. U.T.I.s are responsible for the single-greatest use of antibiotics outside a hospital setting.
“Uncomplicated U.T.I.s are a very common condition impacting women and one of the most frequent reasons for antibiotic use,” Dr. Peter Kim, director of the Division of Anti-Infectives at the F.D.A.’s Center for Drug Evaluation and Research, said in a statement. “The F.D.A. is committed to fostering new antibiotic availability when they prove to be safe and effective.”
Utility Therapeutics, the U.S. company that acquired the rights to pivmecillinam, said it would be available in 2025. The company is also seeking F.D.A. approval for an intravenous version of the drug that is used for more serious infections and is usually administered in a hospital setting.
Health practitioners said they were elated to have another tool in their arsenal given the growing challenge of antimicrobial resistance, which makes existing medications less effective as pathogens mutate in ways that allow them to survive a course of antibiotics.