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Iterum Therapeutics launches ORLYNVAH™, the first and only oral penem antibiotic in the U.S.
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A new FDA-approved antibiotic for adult women with uncomplicated urinary tract infections (uUTIs), ORLYNVAH™ (sulopenem etzadroxil and probenecid) oral tablets, has been officially launched in the U.S. by Iterum Therapeutics plc

This drug is intended for patients with infections caused by E. coli, K. pneumoniae, or P. mirabilis who have limited or no other effective oral treatment options. ORLYNVAH™ marks a significant development as the first oral penem antibiotic to become commercially available in the U.S. and the first new branded product for uUTI in over 25 years. This launch is crucial given the growing crisis of antibiotic resistance, which is affecting a condition that impacts 60% of women in their lifetime. According to a 2024 study, more than half of initial uUTI infections were resistant to at least one class of antibiotic, highlighting the urgent need for new therapies.

The availability of ORLYNVAH™ offers a much-needed alternative for both patients and clinicians. Dr. Marjorie Golden, Site Chief of Infectious Disease at Yale New Haven Hospital, emphasized that this new treatment provides a safe and effective option with impressive efficacy data. She noted that for patients who have exhausted other options, ORLYNVAH™ allows for treatment to occur in the community, potentially reducing the need for emergency room visits and hospitalizations and thereby improving patients' quality of life. Corey Fishman, CEO of Iterum Therapeutics, stated that the company’s mission is to address the substantial unmet medical needs of patients with multi-drug-resistant infections, and the introduction of this first-ever FDA-approved oral penem is a proud moment in that effort.

To improve patient access to this new medication, Iterum Therapeutics is launching a copay savings program, which will allow eligible patients to obtain ORLYNVAH™ for as little as $25. The company specializes in developing differentiated anti-infectives to combat multi-drug-resistant pathogens. ORLYNVAH™ represents a major step in this mission, demonstrating potent activity against a wide variety of bacteria that have become resistant to other antibiotics. The drug has also received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations in multiple indications, underscoring its potential importance in the fight against antibiotic resistance.

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