Iterum Launches First Oral Penem Antibiotic for UTIs in the US

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. 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 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 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.” 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.” “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. 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. About ORLYNVAH™ ORLYNVAH™ is a novel oral penem antibiotic for the treatment of uUTIs. ORLYNVAH™ possesses potent activity against species of Enterobacterales including those that encode ESBL or AmpC-type ß-lactamases that confer resistance to third generation cephalosporins.