Iterum Therapeutics has announced the US Food and Drug Administration (FDA) approval for Orlynvah (sulopenem etzadroxil and probenecid) to treat adult women with uncomplicated urinary tract infections (uUTIs).
Orlynvah is an oral penem antibiotic for the treatment of uUTI.
It targets infections caused by bacteria including Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis in women who have limited or no alternative oral antibacterial therapy options.
This approval marks the first approved indication for Orlynvah which is now the inaugural FDA-authorised product for Iterum Therapeutics.
The regulator had previously declined to approve the antibiotic in 2021, requesting more data.
Iterum Therapeutics re-submitted its application after late-stage trials demonstrated the drug’s safety and tolerability.
The FDA approved the therapy based on a clinical development programme supported by a strong clinical data package. This included two Phase 3 trials, named SURE 1 and REASSURE.
Both trials 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 demonstrated Orlynvah’s effectiveness over ciprofloxacin in treating fluoroquinolone-resistant infections.
REASSURE showed that the drug was non-inferior and statistically superior to Augmentin in susceptible patients.
Orlynvah was generally well tolerated in both trials.
Iterum Therapeutics CEO Corey Fishman said: “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.”
In January, the Irish pharma company announced its intention to sell or licence Orlynvah’s rights.
Iterum Therapeutics plans to launch the penem antibiotic commercially around mid-2025.
The oral antibiotic is now the second FDA-approved therapy for uUTIs in the past two decades.
In April, the FDA approved Utility Therapeutics’ Pivya (pivmecillinam) tablets for the treatment of females with urinary tract infections.
