Iterum Therapeutics has received FDA approval for ORLYNVAH™ (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women who have limited or no alternative oral antibacterial treatment options. This marks the first FDA-approved product for Iterum and the first oral penem antibiotic approved in the U.S.
The approval of ORLYNVAH™ addresses uUTIs caused by designated microorganisms such as Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis. This provides a new treatment option for a condition that affects millions of women each year.
Clinical Significance
ORLYNVAH™ represents a significant advancement in the treatment of uUTIs, offering an oral alternative when other options are limited. According to Iterum, it is only the second FDA-approved treatment for uUTIs in the past two decades. The drug's approval fills a critical gap in the treatment landscape, providing a much-needed option for patients with limited alternatives.
Company Insights
Iterum Therapeutics hosted a conference call on October 28, 2024, to discuss the FDA approval. Speakers included CEO Corey Fishman and Senior Vice President Steve Aronin. During the call, they highlighted the importance of this milestone for the company and discussed plans for the commercial launch of ORLYNVAH™.
About Sulopenem
Sulopenem is a novel penem anti-infective compound with both oral and IV formulations. It 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 Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.
