
Iterum Launches UTI Drug, First Oral Penem Antibiotic Commercially Available in US
Key Takeaways
- Orlynvah, the first oral penem antibiotic in the US, addresses multidrug-resistant uUTIs in adult women, offering a new treatment option after 25 years.
- The introduction of Orlynvah is anticipated to reduce emergency department visits and hospital admissions, enhancing patients' quality of life.
Orlynvah is the first new, branded product for the treatment of uncomplicated UTIs to be introduced in the US in more than 25 years.
Dublin, Ireland-based
New and long-awaited treatment
uUTIs are defined as common bladder infections that are confined predominantly to the lower urinary tract in women who are otherwise healthy and have no structural abnormalities (1). The infections are typically caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, and Iterum’s sulopenem etzadroxil/probenecid treatment was green-lighted by FDA in October 2024 for women who have limited or no other alternative oral antibacterial options.
Iterum said that Orlynvah is the first oral penem antibiotic to become commercially available in the United States; it is also the first new, branded product to be introduced for the treatment of uUTIs in the US in more than 25 years (1).
A ‘paradigm shift’?
“Our mission is to create new antibiotics for patients and to be a treatment alternative to address substantial unmet medical needs in the community,” said
“For patients who currently have limited treatment options, Orlynvah provides a long overdue oral alternative that allows for treatment in the community,” Golden said in the Iterum press release (1). “This paradigm shift in the management of patients with uUTI[s] will not only reduce emergency department visits and hospital admissions, but it will also favorably impact patients’ quality of life.”
Potential impacts of resistant uUTIs
According to Iterum, 60% of women experience a urinary tract infection (UTI) in their lifetimes, with 44% experiencing three or more episodes annually (1). Among 150,000 patients with uUTIs in 2024, a US study said, 57% of initial infections were resistant to at least one antibiotic class, and 13% were resistant to three or more.
While UTIs are already the most common outpatient infection among US women, Iterum said that without new and effective therapies, resistant uUTIs may contribute to inflated healthcare costs, not to mention increasing the number courses of therapy, or amount of emergency room visits and hospitalizations, that women may experience (1).
“The availability of Orlynvah is tremendous news for clinicians and patients alike,” Golden said (1). “The launch of Orlynvah provides a new treatment option with impressive efficacy data to treat appropriate adult women suffering from difficult-to-treat uUTIs.”
More companies focusing on UTIs
Other treatments for various forms of UTIs are in development.
For complicated UTIs (cUTIs), which carry a high risk of clinical complications including but not limited to sepsis and septic shock, an investigational oral treatment has been developed by
In the US, an estimated 2.9 million cases of cUTIs are treated annually (3).
References
1. Iterum Therapeutics.
2. Barton, C.
3. GSK.
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