The FDA has cleared Iterum’s oral antibiotic for certain patients with uncomplicated urinary tract infections (uUTIs) who have limited or no alternative oral options.
Orlynvah, also known as oral sulopenem, will join a host of antibacterials already on the market for uUTIs. But because of growing antimicrobial resistance and unwanted side effects with some drugs, the company sees a chance to fill an unmet medical need. The drug will also be the first oral drug in a class of antibiotics known as “penems.”
Corey FishmanIterum is now looking for a partner with “enough resources to be able to support an appropriate launch,” CEO Corey Fishman said in an interview with Endpoints News. If it can find a partner, Orlynvah could hit the market by the middle of next year. If not, Fishman said “we would consider doing it on our own.”
“But we, of course, would have to raise substantial capital to do it,” he said.
While the company had applied for broad use in adults with uUTIs, Fishman said the FDA’s label restrictions are “very consistent with how we’ve been thinking the whole time.” The drug is approved specifically for women with uUTIs caused by three microorganisms — Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis — who have limited options.
Uncomplicated UTIs are one of the most frequently diagnosed bacterial infections in the US, generating millions of office visits per year, according to research from UCSF’s Department of Clinical Pharmacy. But last month, an FDA advisory committee that reviewed the company’s drug raised concerns about the risks of increasing antimicrobial resistance by opening the door to potential misuse.
“We’re not for the otherwise healthy, younger adult woman who has a UTI,” Fishman told Endpoints News on Friday. “What we’ve always said is we are for that at-risk patient, that higher-risk patient, and I think the label supports that.”
That jibes with the FDA’s concerns, which in briefing documents for the advisory committee said that an oral penem could result in “inappropriate and/or extensive use,” potentially leading to cross-resistance with carbapenems, a class of antibiotics commonly used for severe infections or in patients resistant to other antibiotics.
“How would we feel as providers if we gave somebody courses of a penem antibiotic for a non-life threatening uncomplicated urinary tract infection, and then a month later, or two months later, or three months later, that patient gets admitted with sepsis due to a penem-resistant organism and dies from that infection?” asked Arjun Srinivasan, a deputy director in the CDC’s Division of Healthcare Quality Promotion, during the committee discussion in September.
The FDA rejected the drug in 2021, citing a “lack of substantial evidence of effectiveness.” This time around, Iterum submitted new data showing it was superior to an oral amoxicillin/clavulanate regimen on overall clinical and microbiological response in patients susceptible to the comparator.