The regulator on Wednesday gave its approval for a new oral antibiotic to treat uncomplicated urinary tract infections in women. UTILITY therapeutics expects to launch Pivya in the U.S. in 2025.
The FDA on Wednesday approved the use of UTILITY therapeutics’ oral antibiotic pivmecillinam, which will now carry the brand name Pivya, for the treatment of adult women with uncomplicated urinary tract infections.
In its approval announcement, the FDA noted that uncomplicated urinary tract infections (UTIs) are bacterial infections of the bladder in females with no structural abnormalities of their urinary tract. The regulator added that approximately one-half of all women experience at least one UTI in their lifetime.
Pivya is indicated for patients whose UTIs are caused by susceptible strains of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. UTILITY is working to make Pivya available in the U.S. in 2025, according to reporting from The New York Times.
The antibiotic’s approval “will provide an additional treatment option for uncomplicated UTIs,” Peter Kim, director of the Division of Anti-Infectives at the FDA’s Center for Drugs Evaluation and Research, said in a statement. “Uncomplicated UTIs are a very common condition … and one of the most frequent reasons for antibiotic use.”
The FDA’s approval on Wednesday was supported by data from three clinical trials, which compared Pivya to placebo, another oral antibacterial agent as well as to the anti-inflammatory drug ibuprofen. All three studies primarily evaluated Pivya’s composite response rate, which included clinical cure and microbiological response.
In the placebo study, Pivya treatment elicited a 62% composite response rate at eight to 14 days after enrollment. Only 10% of placebo counterparts achieved the composite response endpoint. When compared with another antibacterial agent, Pivya elicited a 72% composite response rate versus 76% in those who received the other drug.
In the third trial, 66% of patients treated with Pivya achieved composite response compared to only 22% of those who were given ibuprofen.
In terms of safety, Pivya was overall well-tolerated and its most common side effects were nausea and diarrheas.
The antibiotic carries warnings for hypersensitivity reactions, carnitine depletion, Clostridioides difficile-associated diarrhea and severe cutaneous adverse reactions. It should not be taken by patients with known histories of severe hypersensitivities against beta-lactam drugs. Pivya can also interfere with a newborn screening test for the rare metabolic disorder isovaleric acidemia.
Pivya’s active ingredient pivmecillinam is an aminopenicillin, which is a specific subclass of beta-lactams that work by disrupting the synthesis of the bacterial cell wall. According to UTILITY’s website, pivmecillinam has already been commercially approved for more than 40 years outside the U.S. and has long been used to successfully treat UTIs. Pivmecillinam has also been recommended as the frontline treatment option in many countries.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
