The agency approved pivmecillinam tablets for adult women with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus, an April 24 FDA news release said.
The approval for Pivya was given to Utility Therapeutics, a U.S. company that acquired the rights to the drug. It is expected to become available in 2025.
In clinical trials, Pivya outperformed placebo (62% vs. 10%) and ibuprofen (66% vs. 22%) for achieving composite response and was comparable to another oral antibacterial drug (72% vs. 76%).
“This is an exciting new possibility for treatment of lower urinary tract infections,” Shruti Gohil, MD, a professor of infectious diseases at the University of California, Irvine School of Medicine, told The New York Times. “But I would also say that it is going to be important that we use the drug responsibly in this country so that we don’t breed resistance against it.”
Pivmecillinam has been used in Europe for more than 40 years and is often a first-line treatment for uncomplicated UTIs in women. The most common side effects were nausea and diarrhea.
Becker’s 3rd Annual Fall Chief Pharmacy Officer Summit is the top tier event that the people leading the future of pharmacy convene. This 3-day event is built specifically for Chief Pharmacy Officers and senior pharmacy leaders. The sessions examine the workforce, financial and clinical priorities shaping pharmacy today. Becker’s is where candid discussions flourish and new ideas thrive. Becker's 3rd Annual Fall Chief Pharmacy Officer Summit
