After Prior Rejection, Iterum Nabs Long-Sought FDA Nod for Oral UTI Drug Orlynvah

After Prior Rejection, Iterum Nabs Long-Sought FDA Nod for Oral UTI Drug Orlynvah

By, Admin 26 October 2024

Overview

The FDA based its approval of Iterum Therapeutics' Orlynvah on data from two phase 3 trials, coded SURE 1 and REASSURE, which pitted sulopenem against ciprofloxacin and Augmentin, respectively. (mi-viri/iStock/Getty Images Plus)
Despite recent concerns from the FDA about potential off-label use and antimicrobial resistance, Dublin-based Iterum Therapeutics has scored a green light for its oral antibiotic sulopenem.

Sulopenem Approval

Sulopenem, which will now go by the commercial moniker Orlynvah, was approved by the FDA Friday to treat uncomplicated urinary tract infections (uUTIs) caused by E. coli, Klebsiella pneumoniae or Proteus mirabilis in adult women who have limited or no alternative antibacterial treatment options.

Approvals for uUTI Medicine

The FDA nod—Iterum’s first—marks the second approval this year for a uUTI medicine after two decades of stagnation in the field. It also represents the first U.S. approval for an oral penem—a class of antibiotics.

FDA Approval for Pivmecillinam

  • Back in April, the FDA approved Utility Therapeutics’ Pivya (pivmecillinam). 
  • The penicillin antibiotic underpinning Utility’s drug had never before been cleared in the U.S., despite being approved in Europe for more than 40 years.

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  • The FDA based its approval of Iterum’s Orlynvah on data from two phase 3 trials, coded SURE 1 and REASSURE, which pitted Orlynvah against ciprofloxacin and Augmentin (amoxicillin/clavulanate), respectively.

About SURE 1

  • In SURE 1, Orlynvah beat out ciprofloxacin at treating infections in patients who were resistant to the control antibiotic. 
  • Iterum’s candidate proved inferior to the control drug in patients for whom ciprofloxacin still worked.
  • That led the FDA to reject Iterum’s application in 2021 and call on the company to run a second study “potentially using a different comparator drug.”

Iterum did just that with the REASSURE study. In January, the company unveiled data from the phase 3 trial showing Orlynvah was statistically superior to Augmentin, producing a 62% response rate versus 55% for the older antibiotic.

Words from the CEO: Iterum

  • 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,” Iterum’s CEO, Corey Fishman, said in a statement. 
  • With an FDA approval in hand, Iterum will now “renew” its efforts to lock down a “strategic transaction” involving the drug, the chief executive added.

Even after presenting promising phase 3 results from the REASSURE study, Iterum’s Olynvah approval was far from a done deal.

Concerns for “inappropriate use: - Early last month, the FDA convened an advisory committee to weigh concerns that “inappropriate use” of the treatment could lead to further antimicrobial resistance.

Use of Penems

  • While penems are already widely used intravenously thanks to their confirmed efficacy and safety, patients have previously needed to receive treatment in hospital settings, an Iterum spokesperson explained over email. 
  • As an oral alternative to a proven antibiotic, Orlynvah will likely be available via outpatient visits, the FDA noted last month.

Iterum, for its part, plans to share more about its post-approval plans during a conference call Monday morning.

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