On Friday, Iterum Therapeutics plc (NASDAQ:ITRM) received FDA approval for its Orlynvah (sulopenem etzadroxil and probenecid) for uncomplicated urinary tract infections (uUTIs) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.
This is the first approved indication for Orlynvah and the first FDA-approved product for Iterum.
The FDA approval was based on a clinical development program, including two Phase 3 clinical trials (known as SURE 1 and REASSURE) that evaluated the safety and efficacy of Orlynvah compared to ciprofloxacin (SURE 1) and Augmentin (REASSURE) in the treatment of adult women with uUTI.
SURE 1 showed superiority to ciprofloxacin in fluoroquinolone-resistant infections, while REASSURE showed non-inferiority and statistical superiority to Augmentin in the Augmentin susceptible population.
"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," said Corey Fishman, Iterum's CEO.
"As the first oral penem approved in the U.S., 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 maximizing value for our stakeholders."
In July 2021, the FDA issued a Complete Response Letter (CRL) regarding sulopenem etzadroxil/probenecid (oral sulopenem).
The FDA determined that additional data are necessary to support approval.
The agency asked for at least one additional clinical trial, potentially using a different comparator drug, and conduct a further non-clinical investigation to determine the optimal dosing regimen.
Price Action: ITRM stock is down 14.7% at $1.604 at last check Monday.
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