FDA Approves Oral Sulopenem (Orlynvah) for Uncomplicated UTIs
Key Insights
The FDA has approved Orlynvah (oral sulopenem) for uncomplicated urinary tract infections (search) (uUTIs) in adult women with limited oral antibacterial options.
Approval was based on SURE 1 and REASSURE phase 3 trials, demonstrating noninferiority or superiority to comparators like ciprofloxacin and amoxicillin/clavulanate (search).
Orlynvah represents the first oral penem antibiotic approved in the US, offering a new treatment alternative amid rising antibiotic resistance.
The U.S. Food and Drug Administration (FDA) has granted approval to Orlynvah (oral sulopenem), a novel oral penem antibiotic developed by Iterum Therapeutics (search), for the treatment of uncomplicated urinary tract infections (search) (uUTIs) in adult women. This approval addresses infections caused by susceptible isolates of Escherichia coli (search), Klebsiella pneumoniae (search), or Proteus mirabilis (search), specifically in cases where patients have limited or no alternative oral antibacterial treatment options.
The FDA's decision was supported by data from the pivotal SURE 1 and REASSURE phase 3 clinical trials. The SURE 1 trial compared oral sulopenem to ciprofloxacin, demonstrating superiority in fluoroquinolone-resistant infections and non-inferiority in quinolone-susceptible uropathogens. The REASSURE trial compared oral sulopenem to oral amoxicillin/clavulanate (search), showing non-inferiority and statistical superiority in overall response rate (combined clinical cure plus microbiologic eradication).
"The FDA approval of Orlynvah is tremendous news for those of us who have been hoping for a new option to treat appropriate at-risk patients suffering from UTIs," said Marjorie Golden, MD, site chief of infectious diseases on the St. Raphael Campus at Yale New Haven Hospital. "Based on the totality of clinical data generated, ORLYNVAH has the potential to be an important treatment alternative for use in the community."
Addressing Unmet Needs in UTI Treatment
UTIs are a common ailment, with up to 60% of women experiencing one in their lifetime and up to 40% of those with a history of uUTIs suffering recurrent infections. Approximately 40 million uUTI prescriptions are written annually in the US. The increasing prevalence of antibiotic resistance, coupled with an aging population and the suboptimal safety profiles of existing oral treatments, presents challenges for physicians in selecting appropriate antibiotics.
Antimicrobial Resistance Considerations
The approval of oral sulopenem followed a meeting of the FDA's Antimicrobial Drugs Advisory Committee, where potential benefits and risks associated with the drug's approval were discussed. A key concern raised was the potential contribution of sulopenem to antimicrobial resistance. The committee suggested that a narrow indication and post-market surveillance of antimicrobial resistance rates would be necessary.
Company Perspective
"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," said Corey Fishman, chief executive officer, Iterum. "As the first oral penem approved in the U.S., Orlynvah offers an excellent alternative treatment option for appropriate patients in the underserved uUTI market."