Iterum Therapeutics launches new oral antibiotic for urinary tract infections

News brief

Drugmaker Iterum Therapeutics today announced the US commercial launch of its new oral antibiotic for uncomplicated urinary tract infections (uUTIs).

The antibiotic, Orlynvah (sulopenem etzadroxil and probenecid), is a broad-spectrum oral penem antibiotic that's indicated for treating uUTIs caused by certain bacteria (Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis) in adult women who have limited or no alternative treatment options. Approved by the US Food and Drug Administration in October 2024, it's the first oral penem antibiotic commercially available in the United States.

uUTIs are one of the most common bacterial infections experienced by women, accounting for roughly 40 million antibiotic prescriptions a year in the United States alone. But antibiotic resistance is rising in the pathogens that typically cause uUTIs, making them more difficult to treat. A 2024 study cited by Iterum found that, in 150,000 US patients with uUTIs, 57% had infections that were resistant to at least one antibiotic class, and 13% had infections resistant to three or more.

A 'long overdue' oral alternative

"For patients who currently have limited treatment options, Orlynvah provides a long overdue oral alternative that allows for treatment in the community," Marjorie Golden, MD, chief of infectious diseases at the Saint Raphael Campus of Yale New Haven Hospital, said in an Iterum press release. "This paradigm shift in the management of patients with uUTI will not only reduce emergency department visits and hospital admissions, but it will also favorably impact patients’ quality of life."

The FDA approval of Orlynvah came despite some concerns shared with the agency by members of the Antimicrobial Drugs Advisory Committee, who cautioned that off-label use could amplify resistance to carbapenems, which are closely related to penems and are an important class of antibiotics for serious, multidrug-resistant infections. 

The FDA's full prescribing information states that Orlynvah should be used only to treat uUTIs that are proven or strongly suspected to be caused by susceptible bacteria. 

Current and former HHS staff respond to violent CDC attack

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In response to the August 8 armed attack on the US Centers for Disease Control and Prevention (CDC) campus in Atlanta,  more than 800 current and former Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIA), and Department of Health and Human Services (HHS) signed a letter to HHS Secretary Robert F. Kennedy, Jr., and members of Congress airing concerns about America’s health and security. 

CDC HQ
csraphotography / iStock

They said the violent attack wasn’t random and came amid growing mistrust in America’s public institutions, fueled by politicized rhetoric that has turned public health professionals from trusted experts to targets of villanization and violence.  “When a federal health agency is under attack, America’s health is under attack. When the federal workforce is not safe, America is not safe,” they wrote.

Many of the signatories signed their names, but many others signed anonymously due to fears of retaliation and for personal safety.

Group calls on Kennedy to uphold pledge to safeguard the American public

Kennedy is complicit in dismantling the US public health infrastructure and endangering the nation’s health by sowing scientific misinformation. They also said the HHS secretary has questioned the integrity of the CDC’s workforce, creating gaps in preparedness, worker safety, and chronic disease prevention by indiscriminate staff cuts, falsely claiming that mRNA vaccines aren’t effective, cancelling mRNA vaccine development contracts, undermining public trust in the measles, mumps, and rubella (MMR) vaccine, replacing the vaccine advisory committee, and making false claims about vaccines and autism. 

“These dangerous and deceitful statements and actions have contributed to the harassment and violence experienced by CDC staff,” the group wrote.

They called on Kennedy to uphold his pledge to safeguard the American public by taking several steps by September 2, which include ceasing the spread of inaccurate health information, affirming the CDC’s integrity, and guaranteeing the safety of the HHS workforce. The group also honored Officer David Rose who was killed while responding to the attack, making the ultimate sacrifice to protect others. “We extend our deepest gratitude for his service.”

Survey: Depression, anxiety rates rose across racial groups in height of pandemic, with persistent or widened gaps

News brief
Man in mental health crisis
AnnaStills / iStock

A survey of more than 107,000 US adult participants in the National Health Interview Survey from 2019 to 2022 reveals significantly elevated rates of clinician-diagnosed depression or anxiety, with persistent or widened racial health disparities, amid the COVID-19 pandemic.

For the study, published late last week in BMC Medicine, the Harvard-led research team collected data on self-reported health status (ie, overall health, functional limitations, and depression or anxiety) and healthcare access and affordability. The median age of the 107,230 participants was 48.1 years, 51.6% were women, 64.5% were White, 17.3% were Hispanic, 12.1% were Black, and 6.1% were Asian.

"Data suggest that the adverse mental health effects and mental health care during COVID-19 pandemic also differ significantly by age, education, employment status, and income levels," the study authors wrote. 

"Moreover, it is well-known that the COVID-19 pandemic has disproportionately affected disadvantaged populations and communities, further highlighting the importance of social determinants of health in influencing COVID-19 health outcomes," they added.

Insurance access, affordability improved only for Whites

Low-income Black participants had the highest rates of poor or fair health (30.9% in 2019 and 28.4% in 2022), and this racial gap didn't change significantly, regardless of income. 

These trends continue to underscore additional public health and policy interventions are needed to further reduce the racial/ethnic and income disparities in health status and healthcare access and affordability.

The prevalence of depression or anxiety rose over the study period for all racial groups, particularly for Whites (from 32.6% to 38.2%), which the researchers said may reflect this group's relatively restricted neighborhood social cohesion during the pandemic. Functional limitations remained steady, regardless of income. 

Low-income Hispanic respondents had the highest estimated prevalence of limited healthcare access. Health insurance access and affordability significantly improved for low-income White people, but not for other racial groups.

"These trends continue to underscore additional public health and policy interventions are needed to further reduce the racial/ethnic and income disparities in health status and healthcare access and affordability," the researchers wrote. "Also, there is an urgent need to promote psychological health and broaden mental health care access of US adults after the pandemic."

More than 40% of primary care prescriptions contain antibiotics, global study estimates

News brief
Doctor writing a prescription
Francis Black / iStock

The first known global systematic review and meta-analysis of antibiotic prescribing in primary care estimates 42 of every 100 primary care prescriptions contain antibiotics, and more than half are inappropriate, Chinese researchers reported late last week in the American Journal of Infection Control.

The study, led by researchers with Huazhong University of Science and Technology, examined data on primary care prescribing from 174 studies from 51 countries published from January 2000 through September 2023. Sixty-nine of the studies were conducted in high-income countries. The authors note that while primary care settings are recognized as a significant driver of antibiotic use, there are no global estimates of antibiotic prescribing in primary care.

"The absence of comprehensive estimates of global antibiotic prescriptions in primary care could be an important obstacle to the development and implementation of efficient antimicrobial stewardship," they wrote.

High rate of inappropriate antibiotics

The overall pooled prevalence of antibiotic prescriptions in primary care was 42.1% (95% confidence interval [CI], 39.2% to 45.1%), with a significantly higher prevalence observed in lower-middle-income countries (54.0%; 95% CI, 48.7% to 59.2%) and low-income countries (49.1%; 95% CI, 34.0% to 64.3%). The prevalence of antibiotic prescriptions was notably high in primary care in South Asia (54%), the Middle East and North Africa (46.7%), and sub-Saharan Africa (57.2%), and higher in rural areas than in urban areas (51.6% vs 48.0%). 

The pooled prevalence of inappropriate antibiotic prescriptions was 57.6%.

Among the 37 studies that reported on factors associated with antibiotic prescriptions in primary care, the only significant association observed was with higher educational levels of patients (odds ratio [OR], 0.76; 95% CI, 0.71 to 0.82).

The analysis also found no significant decline in antibiotic prescribing over 20 years, a finding the authors say suggests that current antimicrobial stewardship strategies need to be re-evaluated.

"Future research should focus on the feasibility of antimicrobial stewardship patterns to identify important aspects of effective policy implementation," they wrote.

Quick takes: California plague case, US measles rise, UK ups avian flu risk

News brief
  • In California, El Dorado County health officials yesterday announced a human plague case involving a South Lake Tahoe resident. The patient, who is recovering at home, probably contracted Yersinia pestis bacteria from a flea bite while camping in the South Lake Tahoe area. An investigation is under way. The county reported its last plague case in 2020 in an individual who was likely exposed in the same area. Before that, two people were infected in 2015 after exposure to rodents or their fleas in Yosemite National Park. The sporadic cases were California’s first since 2006. Surveillance had identified the bacteria in 41 ground squirrels and rodents in El Dorado County from 2021 through 2024. Four more were detected in 2025.
  • The US Centers for Disease Control and Prevention (CDC) said today that over the past 2 weeks, it has received reports of 19 more measles cases, bringing the national total to 1,375, the most since the disease was eliminated in the United States since 2000. One more state (Idaho) reported a case, lifting the affected number to 41. Three more outbreaks were reported, making 35 for the year, more than twice as many as last year. Of the cases reported this year, 87% were part of outbreaks. Meanwhile, two states issued alerts about possible exposure linked to sick travelers from out of state. The Wisconsin Department of Health Services reported potential exposure at travel stops in Beloit and Roberts, and the Virginia Department of Health reported possible exposure in the northern part of the state linked to a sick patient who was at Dulles International Airport.
  • The UK Department for Environment, Food, and Rural Affairs (DEFRA) today warned bird keepers of a heightened avian flu risk and urged them to tighten their biosecurity measures. Though the risk applies to poultry farmers, the main threat is currently the coastal regions on bird migration routes and areas of the country where game bird operations are located. An avian flu–prevention zone and mandatory biosecurity measures are already in effect for all of Great Britain, but officials added more biosecurity measures today for England’s game bird facilities. Earlier this month, the UK reported an unusual rise in H5N1 avian flu outbreaks in commercial poultry, with 10 reported over the previous 2 weeks.

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