USA –The U.S. Food and Drug Administration (FDA) has granted approval for Orlynvah, an oral antibiotic designed to address uncomplicated UTIs (uUTIs) caused by resistant bacterial strains in adult women who have limited treatment options.
Developed by Iterum Therapeutics, Orlynvah represents a significant new option for a common yet challenging condition.
Orlynvah combines sulopenem etzadroxil, a broad-spectrum oral penem antibiotic, with probenecid.
Targeting infections caused by bacteria such as Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis, this formulation is especially relevant for patients who face limited alternatives due to increasing antibiotic resistance.
“Orlynvah offers new hope for patients suffering from difficult-to-treat uUTIs,” Iterum’s interim CEO, Corey Fishman, said in a press statement.
“As the first oral penem approved in the U.S., it provides an alternative treatment option in an underserved market.”
Iterum’s introduction of Orlynvah comes amid a broader landscape of evolving antibiotic resistance.
Currently, four primary antibiotics dominate 75% of the uUTI prescription market, but resistance rates exceed 20%, with some cases entirely resistant to existing oral antibiotics.
Clinical trials support FDA approval
The FDA’s decision draws on the results of two Phase 3 clinical trials, REASSURE and SURE-1, which both showed Orlynvah’s effectiveness in tackling uUTIs.
REASSURE Trial: Conducted with 2,241 women with uUTIs, this study demonstrated Orlynvah’s effectiveness in treating infections from pathogens that were susceptible to amoxicillin/clavulanate.
Results revealed a 62% response rate in patients treated with Orlynvah, surpassing the 55% rate in the control group.
SURE-1 Trial: This trial, involving 1,660 women with infections caused by ciprofloxacin-resistant pathogens, demonstrated Orlynvah’s superiority to ciprofloxacin, with a 48% response rate compared to 33% for ciprofloxacin.
Orlynvah’s safety profile was favorable, with the most common side effects including diarrhea, nausea, headache, and vaginal yeast infections. Both trials underscored its effectiveness in cases where typical antibiotic options may fail.
Addressing unmet needs and challenges
UTIs are among the most common bacterial infections, particularly in women, with an estimated 40 million antibiotic prescriptions issued annually in the U.S. alone.
However, resistance to traditional oral antibiotics, such as ciprofloxacin, is a growing concern, leading to limited options for patients.
Orlynvah’s development addresses a critical gap in treatment, providing an alternative for resistant infections.
However, concerns remain regarding the potential misuse of this powerful antibiotic. Off-label prescribing could accelerate antimicrobial resistance (AMR), particularly against carbapenems, a related class of antibiotics crucial for treating multidrug-resistant infections.
FDA and advisory committee emphasize responsible use
The FDA and its Antimicrobial Drugs Advisory Committee acknowledged Orlynvah’s benefits while stressing the importance of antimicrobial stewardship.
“While an oral penem for resistant bacteria causing uUTIs can address an unmet need, its use in an outpatient setting requires cautious application to prevent inappropriate use and safeguard against AMR,” noted the FDA in its briefing.
Orlynvah has not been approved for complicated UTIs or intra-abdominal infections, and the FDA recommends it only for uUTIs confirmed to be caused by susceptible bacteria.
This ensures that its use aligns with appropriate treatment hierarchies and safeguards effectiveness.
