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Nearly half of women will get a urinary tract infection in their lifetime. For the first time in more than 20 years the FDA has approved an antibiotic to treat the condition. For the first time in more than 20 years, the FDA has approved a treatment for uncomplicated urinary tract infections (uUTI). And the nod has come for an oral antibiotic that has been available in Europe for more than 40 years. It’s an odd set of circumstances and a dose of foresight by Utility Therapeutics that bring Pivya (pivmecillinam) to the market in the United States in the therapy’s golden years. The London-based company was formed specifically to develop and commercialize pivmecillinam in the U.S. where antimicrobial resistance is growing to standard of care antibiotics. The decreased “utility” of first-line antibiotics and the void the company is attempting to fill in the U.S. were the inspiration of the name of the company. And the void is significant as more than 30 million uUTIs are diagnosed every year in the U.S., with nearly half of all women contracting the infection at some point in their life. Outside of hospital setting, UTIs account for more antibiotic use than any other disorder. In 2018, Utility inked a licensing agreement with LEO Pharma, acquiring the U.S. rights to pivmecillinam and its subcutaneous formulation mecillinam, which the company has submitted for approval as a first-line therapy for complicated urinary tract infections (cUTI) in the hospital setting. The difference between cUTIs and uUTIs is that the former has reached the kidneys while the latter is limited to the bladder. “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,” Peter Kim, M.D., the director of the Division of Anti-Infectives at the FDA’s Center for Drug Evaluation and Research, said in a release. The year that Utility acquired the rights to pivmecillinam and mecillinam, the FDA signed off on each as a Qualified Infectious Disease Product (QIDP). The status is extended to antibacterial and antifungal drug candidates intended to treat serious or life-threatening infections. When a QIDP treatment is approved, it gains an additional five years of market exclusivity. On the same day in January, when Utility revealed that the FDA had accepted the company’s new drug applications for pivmecillinam and mecillinam, it also announced it had received private funding from the AMR Action Fund. The global initiative—which was established by several prominent drugmakers including Amgen, Bayer, Eli Lilly, GSK, Novo Nordisk and Roche—invests in the development of new antimicrobial therapeutics. In addition to being a prodrug, which means that it is not pharmacologically active until it is digested and absorbed into the system, Pivya has a unique mechanism of action, targeting penicillin binding protein-2 in the cell wall of gram-negative bacteria. Pivya’s efficacy was assessed in separate trials versus placebo, an oral antibacterial and ibuprofen. The primary measure of efficacy in the studies was the composite response rate, which included clinical cure (resolution of the symptoms of the uUTI that were present in patients at trial entry and no new symptoms) and microbiological response (demonstration that the bacteria cultured from patients’ urine at trial entry was reduced). In the placebo trial, 62% of the participants who received Pivya achieved composite response compared to 10% of those on placebo. In the oral antibacterial trial, 72% of the subjects who received Pivya achieved composite response versus 76% of those on the comparator. In the third trial, 66% of the subjects who received Pivya achieved composite response compared to 22% of those on ibuprofen.  Commonly prescribed drugs for uUTIs in the U.S. are bactrim (sulphamethoxazole/trimethoprim), nitrofuranatoin and fluoroquinolones. But more than 1 in 5 who receive these are resistant, which can lead to progression of the disease, including life-threatening sepsis. Last month, Germany’s Allecra Therapeutics scored FDA approval for its antibiotic Exblifep, which is a combination of cephalosporin antibacterial cefepime and the beta-lactamase inhibitor enmetazobactam, to treat cUTI. The approval came days after the U.S. regulator rejected another combo therapy in the same indication from Venatorx Pharmaceuticals and Melinta Therapeutics.

UTILITY has received a Prescription Drug User Fee Act (PDUFA) target action date of April 24, 2024 FDA granted Qualified Infectious Disease Product (QIDP) designation for PIVYA in 2018, which provides an additional 5 years of data exclusivity upon approval LONDON, UK / ACCESSWIRE / January 17, 2024 / UTILITY therapeutics Ltd., a biotechnology company focused on the development and commercialization of two European-approved antibiotics for the treatment of urinary tract infections (UTIs) in the U.S., today announced a private financing led by the AMR Action Fund. In addition, UTILITY announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for PIVYA (pivmecillinam) for the treatment of uncomplicated UTIs (uUTI). The FDA granted Priority Review of the NDA with a Prescription Drug User Fee Act (PDUFA) target action date of April 24, 2024. Pivmecillinam is a European-approved, oral prodrug of mecillinam. Pivmecillinam has a unique mechanism of action and targets penicillin binding protein-2 (PBP-2) in the cell wall of gram-negative bacteria. UTILITY has received the FDA's qualified infectious disease product (QIDP) designation for pivmecillinam for the treatment of uUTI. The FDA's QIDP designation is for antibacterial and antifungal drug candidates intended to treat serious or life-threatening infections, and it provides an additional five years of market exclusivity. "The number of safe, effective antibiotics that clinicians have at their disposal continues to dwindle in the face of rising rates of antimicrobial resistance," said AMR Action Fund CEO Henry Skinner, PhD. "Bringing pivmecillinam to the U.S. will give clinicians an important tool to help patients suffering from urinary tract infections and support efforts to enhance global access to this drug." "We are grateful to the AMR Action Fund for its leadership and support to bring this much-needed antibiotic to the US market for uUTI," said Tom Hadley, President and CEO of UTILITY therapeutics. "We believe that PIVYA can be utilized as a first-line therapy where many of the current therapeutic options are limited due to efficacy, safety, and/or rising rates of resistance. Given there has not been a new antibiotic approved in the U.S. for the treatment of uUTI in over 20 years, the priority review by the FDA for PIVYA is an important step to providing a new option to physicians and patients as antimicrobial resistance continues to rise." "This unique mechanism leads to favorable stability against beta-lactamase hydrolysis compared to other penicillins. In more than 30 million courses of treatment administered across Europe, oral pivmecillinam has demonstrated strong clinical cure rates with no serious adverse events observed, while maintaining a low resistance rate of approximately 5%," said Professor Morten Sommer, co-founder of UTILITY. About UTILITY therapeutics Ltd. UTILITY has exclusive U.S. commercial rights to two European-approved antibiotics, pivmecillinam and mecillinam, for the treatment of urinary tract infections (UTI). Pivmecillinam is an oral prodrug of mecillinam that is being developed for uncomplicated UTI (uUTI), and it has a unique mechanism of action for infections caused by Gram-negative bacteria, including extended-spectrum beta-lactamases. Mecillinam, an intravenous (IV) formulation, is being developed as a first-line therapy for complicated UTI (cUTI) in the hospital setting. UTILITY has received the FDA's qualified infectious disease product (QIDP) designation for pivmecillinam for the treatment of uUTI, and IV mecillinam followed by oral pivmecillinam as step-down, carbapenem-sparing therapy for cUTI. This therapeutic regimen allows patients to complete their treatment outside of hospital and reduces the economic burden of cUTI to both patients and payers. The FDA's QIDP designation is for antibacterial and antifungal drug candidates intended to treat serious or life-threatening infections, and provides an additional five years of market exclusivity and potentially includes Priority Review. For additional information, please visit . Contact Tom Hadley Chief Executive Officer Tel: +1 (973) 224-7272 info@utilitytherapeutics.com SOURCE: Utility therapeutics Ltd. View the original press release on accesswire.com