FDA Grants Priority Review to European-Approved UTI Antibiotic

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Utility Therapeutics, a UK-based biotechnology company, announced that the FDA has granted priority review to its new drug application (NDA) for pivmecillinam, a European-approved treatment of uncomplicated urinary tract infections (UTIs).¹

According to Medscape, UTIs occur far more frequently in women, with 20% having at least one in their lifetime. It is responsible for at least 8 million visits to healthcare facilities in the US per year. Bladder infection is the most common type of UTI.²

Pivmecillinam, marketed under the brand name Pivya, has been used outside of the United States to treat uncomplicated UTIs for over 40 years. According to a Utility Therapeutics press release, the antibiotic has a clinical cure rate of 95% and it is recommended as a first-line option for UTI treatment in many countries, including Denmark.

"This is a product that's been well-studied, it's been widely used across Europe, and it's on numerous guidelines as a first-line option," said Utility President and CEO Tom Hadley in a press release.

Utility Therapeutics acquired US rights to the drug in 2018 along with mecillinam, an intravenous formulation for which the company has submitted an NDA. Both drugs received the FDA's qualified infectious drug product designation in 2018. According to the release, if pivmecillinam is approved by the FDA, it would be the first new antibiotic approved in the United States for uncomplicated UTIs in over 20 years.

Hadley added in the press release that three of the most commonly prescribed first-line options for uncomplicated UTIs—nitrofurantoin, Bactrim (sulfamethoxazole and trimethoprim), and fluoroquinolones—are increasingly limited by resistance, efficacy, and safety issues, illustrating a clear unmet need.

"There are 30 million prescriptions written for antibiotics for uncomplicated UTIs every year, and over 90% of those are for those three products," Hadley said in the press release. "There's a huge need, and doctors need options."

The NDA includes six clinical studies supporting pivmecillinam's efficacy and 12 supporting its safety. The FDA is expected to make a decision by April 24, 2024.

In addition to news of the FDA’s priority review, Utility Therapeutics also announced that it has received a new round of funding led by the AMR Action Fund, making it the seventh company to receive funding. The AMR Action fund was established in 2020 and aims to invest more than $1 billion with the goal of bringing two to four new antibiotics to market by 2030.

"The number of safe, effective antibiotics that clinicians have at their disposal continues to dwindle in the face of rising rates of antimicrobial resistance," AMR Action Fund CEO Henry Skinner, PhD, said in another press release from Utility. "Bringing pivmecillinam to the US will give clinicians an important tool to help patients suffering from urinary tract infections and support efforts to enhance global access to this drug."³

References

1. FDA to review European-approved oral antibiotic for urinary tract infections. (17 January 2024). CIDRAP - Center for Infectious Disease Research & Policy Research and Innovation Office, University of Minnesota, Minneapolis, MN. https://www.cidrap.umn.edu/antimicrobial-stewardship/fda-review-european-approved-oral-antibiotic-urinary-tract-infections
2. Urinary Tract Infection (UTI) and Cystitis (Bladder Infection) in Females (26 January 2023). Medscape. https://emedicine.medscape.com/article/233101-overview?form=fpf
3. UTILITY therapeutics Ltd. Announces Financing Led by the AMR Action Fund and FDA Acceptance of PIVYA New Drug Application with Priority Review. (17 January 2024). ACCESSWIRE. https://www.accesswire.com/825382/utility-therapeutics-ltd-announces-financing-led-by-the-amr-action-fund-and-fda-acceptance-of-pivya-new-drug-application-with-priority-review