The US Food and Drug Administration has approved Iterum Therapeutics’ oral antibiotic ITRM approved to treat certain types of bacterial urinary tract infections (UTIs) in adult women, the health agency said Friday.
The drug, Orlynvah, has been approved to treat uncomplicated urinary tract infections in women who have limited or no oral antibacterial treatment options. Urinary tract infections are a common bacterial infection of the bladder that primarily affects women with normal urinary tract anatomy.
According to the company, half of all women in the United States will experience at least one uncomplicated urinary tract infection during their lifetime. Although several antibiotics are approved, some patients have limited options due to side effects and the increase in drug-resistant bacteria.
The company expects to launch Orlynvah around mid-2025, CEO Corey Fishman told Reuters on Thursday.
The regulator’s decision comes after it rejected approval of the drug in 2021, calling for more data. The company then resubmitted its application after late-stage studies showed the drug was well tolerated and had no safety issues.
Last month, the FDA held a meeting with outside advisers to discuss the relative risks or benefits of using the drug, known chemically as sulopenem.
FDA advisers had said that off-label use of the drug could pose high risks, with significant risk to the community and individuals in the form of increasing antimicrobial resistance to carbapenems, the class of antibiotics to which sulopeem belongs .
The company said in January that it would sell or license the rights to the treatment.
CEO Fishman told Reuters on Thursday the company would resume partnership discussions if it receives approval for Orlynvah.
“We believe that any medium or large-sized pharmaceutical company that has products that are already being prescribed, in large part by these physicians, would potentially be a good fit for sulopeem,” Fishman said.
