Iterum Therapeutics launches ORLYNVAH for uncomplicated urinary tract infections.

Iterum Therapeutics has launched ORLYNVAH, a new oral antibiotic for uncomplicated urinary tract infections in adult women, approved by the FDA in October 2024. ORLYNVAH is the first oral penem antibiotic available in the US and the first new branded product for uUTI in over 25 years, offering a critical option for patients and physicians facing a shrinking arsenal of effective oral therapies.

Iterum Therapeutics plc (Nasdaq: ITRM) has announced the U.S. commercial launch of ORLYNVAH™, a novel oral antibiotic for treating uncomplicated urinary tract infections (uUTIs) in adult women. Approved by the FDA in October 2024, ORLYNVAH™ is the first oral penem antibiotic available in the U.S. and the first new branded product for uUTI in over 25 years, offering a critical option for patients and physicians facing a shrinking arsenal of effective oral therapies [1].

The prevalence of uUTIs is significant, with 60% of women experiencing at least one episode in their lifetime and 44% experiencing three or more episodes annually. The condition is the most common outpatient infection in women in the United States, and resistance to antibiotics is on the rise [1]. According to a 2024 U.S. study involving approximately 150,000 patients, 57% of initial infections were resistant to at least one antibiotic class, and 13% were resistant to three or more [1].

The availability of ORLYNVAH™ is a significant development in the treatment of uUTIs. It is designed to combat species of Enterobacterales, including those that encode ESBL or AmpC-type ß-lactamases, which confer resistance to third-generation cephalosporins [1]. This makes it a valuable alternative for patients and physicians facing limited treatment options.

To support patient access, Iterum Therapeutics is launching a copay savings program allowing eligible patients to obtain ORLYNVAH™ for as little as $25 [1]. The company is also focused on creating new antibiotics to address substantial unmet medical needs in the community, with a mission to improve the lives of people affected by serious and life-threatening diseases [2].

The launch of ORLYNVAH™ is a significant milestone for Iterum Therapeutics, demonstrating the company's commitment to innovation in the fight against antibiotic resistance. The success of this product could have a substantial impact on healthcare costs and patient outcomes, reducing the need for additional courses of therapy, emergency room visits, and hospitalizations [1].

References:
[1] https://www.nasdaq.com/press-release/iterum-therapeutics-launches-orlynvahtm-first-and-only-oral-penem-antibiotic-us-2025
[2] https://www.globenewswire.com/news-release/2025/08/20/3136342/0/en/Iterum-Therapeutics-launches-ORLYNVAH-the-first-and-only-oral-penem-antibiotic-in-the-U-S.html