The U.S. Food and Drug Administration has approved a new antibiotic named pivmecillinam or Pivya to treat Urinary Tract Infections in women.
Pivya, manufactured by the UK-based Utility Therapeutics Ltd., has been commonly used in Europe for decades to cure uncomplicated UTIs, an acute infection of the bladder with no abnormal structures in the urinary tract.
“UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use,” commented Dr. Peter Kim, head of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research.
“The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Pivya will provide an additional treatment option for uncomplicated UTIs,” Kim added.
The approval was based on three clinical trials conducted on women aged 18 years or older suffering from uncomplicated UTIs. The antibiotic was compared with ibuprofen and a placebo.
The trial results showed that Pivya’s success rate was better than ibuprofen and placebo.
However, FDA advised patients with a known sensitivity towards beta-lactam antibacterials to stay away from the drug.
According to the New York Times, the new antibiotic will be available from 2025.
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