The AMR Action Fund announced today that one of its portfolio companies, UTILITY Therapeutics, Ltd., received approval from the U.S. Food and Drug Administration (FDA) for the antibiotic PIVYA™ (pivmecillinam) for the treatment of uncomplicated UTIs (uUTI). The FDA previously designated pivmecillinam as a qualified infectious disease product (QIDP), a designation reserved for certain antibacterial and antifungal drugs that treat serious or life-threatening infections.

UTIs are one of the most common infections worldwide, disproportionately affecting women and the elderly. There were more than 400 million UTIs globally in 2019, a 60 percent increase since 1990, according to a recent study in Frontiers in Public Health. In the U.S. specifically, UTIs afflict millions of women each year, costing the health system an estimated $2.14 billion annually, according to findings published in Clinical Infectious Diseases.

“Urinary tract infections caused by gram-negative bacteria are a substantial and growing burden, and the efficacy of available first-line therapies is waning in the face of mounting antimicrobial resistance. Bringing pivmecillinam to the U.S. has the potential to benefit patients suffering from these harmful infections by giving clinicians a new, urgently needed treatment option for uncomplicated UTIs,” AMR Action Fund CEO Henry Skinner, PhD, said. “FDA approval also has the potential to support efforts to provide access to this important antibiotic in low- and middle-income countries where it has not yet been approved and where the burden of bacterial infections is enormous and fewer effective therapies are available.”

Pivmecillinam is the first antibiotic in approximately 20 years to be approved by the FDA for uUTI. Pivmecillinam is an oral prodrug of mecillinam that has a unique mechanism of action against gram-negative bacteria and is currently marketed in some European countries. Numerous studies have demonstrated its efficacy and safety profile, and it has maintained a low resistance profile after years of use in Nordic markets.

“Approximately 50 percent of women in the U.S. will suffer from a UTI during their lifetime and treatment options for these often-debilitating infections have lagged,” Beth Battaglino, RN-C, CEO of Healthy Women said. “As rates of antimicrobial resistance continue to rise, we must ensure that healthcare providers have the necessary tools to meet the needs of their patients.”

Michael Hodin, PhD, CEO of the Global Coalition on Aging, added, “Urinary tract infections are a scourge among older adults that are responsible for approximately 25 percent of all geriatric hospitalizations in the U.S. We applaud UTILITY Therapeutics for recognizing where the patient need is, and we commend the AMR Action Fund for supporting UTILITY’s efforts to bring pivmecillinam to patients in the U.S.”

Pivmecillinam marks the first antibiotic drug of an AMR Action Fund portfolio company to earn regulatory approval.

About the AMR Action Fund

The AMR Action Fund is a mission-driven venture capital fund investing in antibiotics, antifungals, and other antimicrobial technologies. The Fund plans to invest approximately US$1 billion into clinical-stage biotech companies to help bring two to four new antibiotics to market by 2030.