Regulatory

FDA Approves Orlynvah for Uncomplicated Urinary Tract Infections in Adult Women

Oct. 30, 2024

Orlynvah, an oral tablet, receives FDA approval for treating uncomplicated urinary tract infections caused by specific bacteria in adult women with limited antibiotic options.

Janette Wider

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On Oct. 24, U.S. Food and Drug Administration (FDA) approved new treatment for uncomplicated urinary tract infections in adult women who have limited or no alternative oral antibiotic treatment options.

The FDA has approved Orlynvah (sulopenem etzadroxil and probenecid) oral tablets for the treatment of uncomplicated urinary tract infection(s) (uUTI) caused by certain bacteria (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 primary or step-down treatment of complicated UTI (cUTI) or complicated intra-abdominal infections (cIAI).

Orlynvah is taken as one oral tablet twice daily for 5 days.

An uncomplicated UTI is a bacterial infection of the bladder in women with no structural abnormalities of their urinary tract. Approximately one-half of all women will experience at least one uUTI in their lifetime.

The effectiveness of Orlynvah was evaluated in two phase 3 controlled, randomized, double blind clinical trials (Trial 1 and Trial 2) which enrolled adult women with uUTI. Orlynvah was administered as one tablet twice daily for 5 days.

Trial 1 (NCT05584657) was a noninferiority trial in which 2214 adult women with uUTI were randomized and treated. Orlynvah demonstrated efficacy in patients with amoxicillin/clavulanate-susceptible pathogens with a composite response rate (combined microbiological response and clinical response) of 62% compared to a composite response rate of 55% in the amoxicillin/clavulanate group. Trial 2 (NCT03354598) was a noninferiority trial in which 1660 adult women with uUTI were randomized and treated. Orlynvah demonstrated efficacy in patients with ciprofloxacin-resistant pathogens with a composite response rate of 48% compared to a composite response rate of 33% in the ciprofloxacin group. Overall, in the two trials combined, 1932 patients were treated with Orlynvah.

Clinical trials evaluating Orlynvah for the treatment of patients with cUTI and cIAI did not demonstrate effectiveness.