Orlynvah (sulopenem etzadroxil and probenecid), the first and only oral penem antibiotic launched in the U.S. – Iterum Therapeutics

Iterum Therapeutics plc announced the U.S. launch of Orlynvah (sulopenem etzadroxil and probenecid) oral tablets. The FDA had 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 U.S. and the first new branded product to be introduced in the U.S. for uUTI in more than 25 years – offering a critical option for patients and physicians facing a shrinking arsenal of effective oral therapies.

In their lifetime 60% of women experience a urinary tract infection and 44% experience three or more episodes annually. It is the most common outpatient infection in women in the United States and resistance continues to increase. According to a 2024 U.S. 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 U.S., including the need for additional courses of therapy, emergency room (ER, A&E) visits or hospitalizations, all of which underscore the urgent need for innovation in this space.

“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.”

“The availability of ORLYNVAH is tremendous news for clinicians and patients alike,” said Dr. Marjorie Golden, 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.” Dr. Golden added, “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.”