FDA Approves Iterum's Oral Sulopenem (ORLYNVAH™) for Uncomplicated Urinary Tract Infections
核心洞察
The FDA has approved ORLYNVAH™ (sulopenem etzadroxil and probenecid) for treating uncomplicated urinary tract infections (搜索) (uUTIs) in adult women with limited oral antibacterial options.
ORLYNVAH™ is the first oral penem antibiotic approved in the U.S., offering a new treatment alternative for uUTIs caused by specific microorganisms.
The approval was based on Phase 3 trials (SURE 1 and REASSURE) demonstrating efficacy and safety compared to ciprofloxacin and Augmentin™.
Iterum Therapeutics (搜索) announced that the U.S. Food and Drug Administration (FDA) has approved ORLYNVAH™ (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (搜索) (uUTIs) in adult women. This approval marks a significant milestone as ORLYNVAH™ is the first oral penem antibiotic to be approved in the U.S. and only the second FDA-approved treatment for uUTIs in the past two decades. The drug is indicated for uUTIs caused by susceptible isolates of Escherichia coli (搜索), Klebsiella pneumoniae (搜索), or Proteus mirabilis (搜索) when there are limited or no alternative oral antibacterial treatment options.
Clinical Trial Data Supporting Approval
The FDA's decision was supported by data from a comprehensive clinical development program, including two pivotal Phase 3 trials, SURE 1 and REASSURE. SURE 1 compared ORLYNVAH™ to ciprofloxacin, demonstrating superiority in fluoroquinolone-resistant infections. REASSURE compared ORLYNVAH™ to Augmentin™, showing non-inferiority and statistical superiority in the Augmentin™-susceptible population. In both trials, ORLYNVAH™ was generally well-tolerated.
Addressing Unmet Needs in UTI Treatment
Urinary tract infections (搜索) are highly prevalent, with up to 60% of women experiencing a uUTI in their lifetime and up to 40% experiencing recurrent infections. Approximately 40 million uUTI prescriptions are written annually in the United States. Rising antibiotic resistance is making treatment more challenging. ORLYNVAH™ offers a potential solution to combat antimicrobial resistance to other approved oral agents.
Mechanism of Action and Spectrum of Activity
ORLYNVAH™ is a novel oral penem antibiotic with potent activity against Enterobacterales species, including those that produce extended-spectrum beta-lactamases (ESBL) or AmpC-type beta-lactamases, which confer resistance to third-generation cephalosporins.
Safety Information
ORLYNVAH™ is contraindicated in patients with a history of hypersensitivity to penems, beta-lactam antibacterial drugs, or probenecid, as well as in patients with blood dyscrasias or uric acid kidney stones. Concomitant use with ketorolac tromethamine is also contraindicated. Common adverse reactions include diarrhea, nausea, vulvovaginal mycotic infection, headache, and vomiting.
Company Strategy
Iterum Therapeutics (搜索) is now focusing on securing a strategic transaction involving ORLYNVAH™ to maximize value for its stakeholders, leveraging the drug's FDA approval and clear label.