Iterum Therapeutics has received the FDA's approval for its oral antibiotic, Orlynvah, for the treatment of uncomplicated urinary tract infections (uUTI).
The sulopenem etzadroxil and probenecid combo can treat UTIs caused by E. coli, K. pneumoniae, or P. mirabilis in adult women.
Notably, Orlynvah is one of two FDA-approved treatments for uUTIs to be approved in the last two decades.
This is the first FDA approval for both Orlynvah and Iterum Therapeutics itself.
The regulatory board's decision was based on the results of two Phase III clinical trials — SURE 1 and REASSURE — which evaluated the safety and efficacy of Orlynvah compared with both ciprofloxacin and Augmentin.
During the SURE 1 trial, Orlynvah was found to be superior to ciprofloxacin in fluoroquinolone-resistant infections.
The antibiotic was also found to be non-inferior and statistically superior to Augmentin within an Augmentin susceptible population.
Iterum Therapeutics' CEO, Corey Fishman, commented: "Orlynvah offers new hope for patients suffering from difficult-to-treat uUTIs. The introduction of novel products, like Orlynvah, is an important way to combat antimicrobial resistance to other approved oral agents and offers a potential solution to patients and physicians,”
“As the first oral penem approved in the US, ORLYNVAH offers an excellent alternative treatment option for appropriate patients in the underserved uUTI market. With FDA approval and a clear label, we will renew our efforts to achieve a strategic transaction involving ORLYNVAH with the goal of maximising value for our stakeholders.”
Marjorie Golden, Site Chief, Infectious Disease, St. Raphael Campus Yale New Haven Hospital, added: “The FDA approval of Orlynvah is tremendous news for those of us who have been hoping for a new option to treat appropriate at-risk patients suffering from UTIs,”
“Based on the totality of clinical data generated, Orlynvah has the potential to be an important treatment alternative for use in the community.”