Orlynvah FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 25, 2024.
FDA Approved: Yes (First approved October 25, 2024)
Brand name: Orlynvah
Generic name: sulopenem etzadroxil and probenecid
Dosage form: Tablets
Company: Iterum Therapeutics plc
Treatment for: Urinary Tract Infection
Orlynvah (sulopenem etzadroxil and probenecid) is a penem antibacterial and renal tubular transport inhibitor combination used for the treatment of uncomplicated urinary tract infections in adult women.
- Orlynvah is indicated for the treatment of uncomplicated urinary tract infections (uUTI) 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.
Orlynvah is not indicated for the treatment of:
- Complicated urinary tract infections (cUTI) or as step-down treatment after intravenous antibacterial treatment of cUTI.
- Complicated intra-abdominal infections (cIAI) or as step-down treatment after intravenous antibacterial treatment of cIAI. - Uncomplicated UTIs are infections of the bladder occurring mainly in women. Complicated UTIs are UTIs that are not uncomplicated, and include UTIs in immunocompromised patients, males, pregnant patients, and those associated with fevers, stones, sepsis, urinary obstruction, catheters, or involving the kidneys.
- There have previously been limited treatment options for uncomplicated urinary tract infections caused by extended-spectrum beta-lactamase (ESBL)-producing, gram-negative pathogens such as Escherichia coli and Klebsiella species. Sulopenem belongs to the penem class of antibacterials which have a structure that renders them highly resistant to beta-lactamases.
- Orlynvah is the first oral penem approved for use in the U.S. and the second FDA-approved treatment for uUTIs in the past two decades. Orlynvah contains sulopenem etzadroxil, a prodrug that is hydrolyzed to the active drug sulopenem after oral administration, and probenecid, a renal tubular transport inhibitor that works to increase plasma concentrations of sulopenem by inhibiting organic anion transporter 3 (OAT3)-mediated renal clearance of sulopenem.
- Sulopenem was discovered in the laboratories of Pfizer Inc. in the 1980s and was first developed with an intravenous (IV) formulation only. The company completed an extensive pre-clinical program, followed by human studies. Later, an oral formulation was developed and tested in Phase 1 and Phase 2 trials. Although the results were encouraging, development of sulopenem was abandoned when Pfizer shifted focus towards other therapeutic areas. In November 2015, Iterum successfully negotiated the license of sulopenem and its prodrugs, and restarted the development program.
- FDA approval of Orlynvah was based on data from the pivotal, Phase 3 clinical trials SURE 1 (which compared Orlynvah to ciprofloxacin) and REASSURE (which compared Orlynvah to Augmentin) in the treatment of adult women with uUTI. SURE 1 showed superiority of Orlynvah compared to ciprofloxacin in fluoroquinolone resistant infections, while REASSURE showed non-inferiority and statistical superiority of Orlynvah compared to Augmentin in the Augmentin susceptible population.
- Orlynvah is administered orally, twice daily with food for 5 days.
- Warnings and precautions associated with Orlynvah include potentially serious hypersensitivity reactions, Clostridioides difficile-Associated Diarrhea (CDAD), and exacerbation of gout.
- Common adverse reactions include diarrhea, nausea, vulvovaginal mycotic infection, headache, and vomiting.
Development timeline for Orlynvah
Further information
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