FDA Approves Oral Sulopenem for the Treatment of Uncomplicated Urinary Tract Infections

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The FDA has approved a new drug application for oral sulopenem (sulopenem etzadroxil and probenecid, Iterum Therapeutics) for the treatment of uncomplicated urinary tract infections (uUTIs) caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options, according to an Iterum Therapeutics news release.¹

Oral sulopenem will be marketed under the name Orlynvah and it is the first oral penem approved in the US, according to Iterum.¹

“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,” Marjorie Golden, MD, site chief of infectious diseases on the St. Raphael Campus at Yale New Haven Hospital, said in an Iterum press release.¹ “Based on the totality of clinical data generated, ORLYNVAH has the potential to be an important treatment alternative for use in the community.”

The FDA approval was based on results from the pivotal SURE 1 and REASSURE phase 3 clinical trials. The SURE 1 trial evaluated the safety and efficacy of oral sulopenem compared to ciprofloxacin, and the REASSURE trial compared it with oral amoxicillin/clavulanate.¹

Results from the SURE 1 study showed superiority to ciprofloxacin in fluoroquinolone resistant infections and noninferiority to ciprofloxacin in the treatment of patients with a quinolone-susceptible uropathogen. Data from REASSURE showed noninferiority and statistical superiority to amoxicillin/clavulanate in regard to the trial’s primary end point of overall response rate (combined clinical cure plus microbiologic eradication) in the treatment of people with uUTI. Oral sulopenem was generally well tolerated in both trials, according to the press release.¹

According to the Iterum news release, up to 60% of women will have a uUTI in their lifetime, and as many as 40% of women with a history of uUTI will have a recurrent infection. There are approximately 40 million uUTI prescriptions generated annually in the US. Rising antibiotic resistance, an aging population with comorbidities, and suboptimal safety profiles of existing oral treatment options are making antibiotic selection more challenging for treating physicians, according to Iterum.¹

The approval of oral sulopenem comes after a meeting of the FDA's Antimicrobial Drugs Advisory Committee to discuss the potential benefits and risks associated with approval of the NDA for oral sulopenem. Specifically, the committee addressed concerns regarding the drug’s contribution to antimicrobial resistance. In the discussion, the members indicated that a more specific and narrow indication may prevent off-label use, and post-market observation of changes to the rates of antimicrobial resistance may be necessary.²

“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,” Corey Fishman, chief executive officer, Iterum, said in the press release.¹ “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.”

References

1. Iterum Therapeutics receives U.S. FDA approval of Orlynvah (oral sulopenem) for the treatment of uncomplicated urinary tract infections. News release. Iterum Therapeutics. Published online and accessed October 25, 2024. https://www.iterumtx.com/news/press-releases/detail/136/iterum-therapeutics-receives-u-s-fda-approval-of
2. Iterum Therapeutics provides update on FDA advisory committee discussion of oral sulopenem for the treatment of uUTI in adult women. News release. Iterum Therapeutics. September 10, 2024. Accessed October 25, 2024. https://www.iterumtx.com/news/press-releases/detail/133/iterum-therapeutics-provides-update-on-fda-advisory