UK-based biotechnology company Utility Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of its new drug application (NDA) for pivmecillinam for the treatment of uncomplicated urinary tract infections (UTIs). Announced.
The company also announced that it has received a new funding round led by AMR Action Fund.
widely used and well-studied antibiotics
Pivmecillinam, sold under the brand name Pivya, is a European-approved oral antibiotic with a unique mechanism of action that has been used outside the United States for more than 40 years to treat uncomplicated urinary tract infections. The clinical cure rate is up to 95%. . It is recommended as a first-line option in many countries, including Denmark, where it has been used as a primary treatment for urinary tract infections for many years.
Utility Therapeutics acquired the U.S. rights to the drug in 2018, along with the intravenous drug mecillinum, for which the company has an NDA for complicated urinary tract infections. Both drugs received FDA Eligible Infectious Disease Drug Product designation in 2018. If the NDA for pivmecillinam is approved by the FDA, it would be the first new antibiotic approved for uncomplicated UTIs in the United States in more than 20 years.
Uncomplicated urinary tract infections are one of the most common reasons for outpatient antibiotic use in the United States and other countries, especially among women, nearly half of whom will develop a urinary tract infection during their lifetime. It will be. However, resistance to first-line antibiotics for uncomplicated urinary tract infections is increasing. World Health Organization 2022 monitoring reportContains data from 87 countries, with over 20% Escherichia coli The isolates that are the most common cause of UTI were resistant to first- and second-line antibiotics.
This is a well-researched product, widely used across Europe, and listed in many guidelines as a first-choice option.
Tom Hadley, the utility's president and CEO, said the three most commonly prescribed first-line options for uncomplicated urinary tract infections are nitrofurantoin, Bactrim ( Sulfamethoxazole and trimethoprim) and fluoroquinolones are increasingly limited by resistance, efficacy, and safety issues, and an unmet need is clear. .
“There are 30 million antibiotic prescriptions for simple urinary tract infections each year, and more than 90 percent of them are for these three products,” Hadley told CIDRAP News. “The need is so great and physicians need options.”
The NDA includes six clinical studies supporting pivmecillinum's efficacy and 12 clinical studies supporting its safety. Hadley said efficacy and safety data support positioning the drug as a first-line option. Furthermore, he points out that despite its widespread use across Europe, resistance rates to pivmecillinum remain in the low single digits.
“This is a well-studied product, widely used across Europe, and listed in many guidelines as a first-line option,” he said.
This also includes the Infectious Diseases Society of America's Simple Urinary Tract Infection Guidelines, which list pivmecillinam as a suitable option in countries where it is available.
According to the company, both pivmecillinam and mecillinum have shown potent activity in vitro and in vivo against multidrug-resistant uropathogens, including extended-spectrum beta-lactamase production. Escherichia coli, This is a growing threat to both hospitals and the community.
Support from AMR Action Fund
With today's announcement, the utility becomes the seventh company to receive funding from the AMR Action Fund. The AMR Action Fund was established in 2020 and aims to invest more than $1 billion over 10 years, with the goal of bringing two to four new antibiotics to market by 2030.
“In the face of rising rates of antimicrobial resistance, the number of safe and effective antibiotics at the disposal of clinicians continues to dwindle,” said Dr. Henry Skinner, CEO of AMR Action Fund. I mentioned it in my paper. press release. “Bringing pivmecillinam to the United States will give clinicians an important tool to help patients suffering from urinary tract infections and support efforts to increase global access to this drug.”
Hadley said the financial support from the AMR Action Fund was validation of Utility's strategy and was critical to helping the company meet FDA requirements under the Prescription Drug User Fee Act.
The FDA is expected to make a decision on the NDA by April 24th.
