Iterum Therapeutics Launches the First & Only Oral Penem Antibiotic in the US

Iterum Therapeutics plc recently announced the US commercial launch of ORLYNVAH (sulopenem etzadroxil and probenecid) oral tablets. The US FDA approved ORLYNVAH for adult women with uncomplicated urinary tract infections (uUTIs) caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis with limited or no alternative oral antibacterial options in October 2024. ORLYNVAH is the first oral penem antibiotic commercially available in the US and the first new branded product to be introduced in the US for uUTI in more than 25 years – offering a critical option for patients and physicians facing a shrinking arsenal of effective oral therapies.

Sixty percent of women experience a urinary tract infection in their lifetime and 44% experience three or more episodes annually. It is the most common outpatient infection in women in the US, and resistance continues to increase. According to a 2024 US study in approximately 150,000 patients with uncomplicated UTIs:

• 57% of initial infections were resistant to at least one antibiotic class; and
• 13% were resistant to three or more.

Without new, safe and effective oral therapies, resistant uUTIs are expected to inflate healthcare costs and may lead to poor patient outcomes in the US, including the need for additional courses of therapy, emergency room visits or hospitalizations, all of which underscore the urgent need for innovation in this space.

“The availability of ORLYNVAH is tremendous news for clinicians and patients alike,” said Marjorie Golden, MD, FIDSA, Site Chief, Infectious Disease, St. Raphael Campus Yale New Haven Hospital. “The launch of ORLYNVAH provides a new treatment option with impressive efficacy data to treat appropriate adult women suffering from difficult-to-treat uUTIs. For patients who currently have limited treatment options, ORLYNVAH provides a long overdue oral alternative that allows for treatment in the community. 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.”

“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 Corey Fishman, Chief Executive Officer of Iterum Therapeutics. “For many people with multidrug-resistant uUTIs, options have been exhausted. We’re proud to introduce ORLYNVAH—the first oral penem ever approved by the FDA—giving clinicians and patients a much-needed new therapy.”

To support patient access, Iterum Therapeutics is launching a copay savings program allowing eligible patients to obtain ORLYNVAH for as little as $25. For more information about ORLYNVAH, including full prescribing information, visit www.ORLYNVAH.com.

Uncomplicated urinary tract infections (uUTIs) are a common bladder infection typically confined to the lower urinary tract in otherwise healthy women with no structural abnormalities of the urinary tract—caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.

Iterum Therapeutics plc is focused on delivering differentiated anti-infectives aimed at combatting the global crisis of multi-drug-resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum is advancing the development of its first compound, sulopenem, a novel penem anti-infective compound, with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum has received US FDA approval for ORLYNVAH (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) caused by Escherichia coli, Klebsiella pneumoniae or Proteus mirabilis in adult women with limited or no alternative oral antibacterial treatment options, and ORLYNVAH is commercially available in the US. Iterum has also been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications. For more information, visit www.iterumtx.com.