After prior rejection, Iterum nabs long-sought FDA nod for oral UTI drug Orlynvah
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, 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.
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.
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.
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.
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.
Even after presenting promising phase 3 results from the REASSURE study, Iterum’s Olynvah approval was far from a done deal. Early last month, the FDA convened an advisory committee to weigh concerns that “inappropriate use” of the treatment could lead to further antimicrobial resistance.
UTIs rank among the most common bacterial infections in the U.S. and beyond. Up to 60% of women will have a uUTI in their lifetime, and up to 40% of women with a history of uUTIs will experience a recurrence of their infection, Iterum noted in its approval release.
Each year, some 40 million uUTI prescriptions are generated in the U.S., and Iterum estimates that about 1% of those infections are caused by pathogens that are resistant to all commonly available oral antibiotics.
