Second Oral UTI Treatment Approved, But Still No Vaccine

For decades, antibiotics have been the primary treatment for urinary tract infections (UTIs) in the United States. However, the growing challenge of antibiotic resistance has prompted the pharmaceutical industry to develop innovative solutions.

To address this need, the U.S. Food and Drug Administration (FDA) announced on October 25, 2024, that it approved Iterum Therapeutics plc's Orlynvah (sulopenem etzadroxil and probenecid) oral tablets for the treatment of uncomplicated urinary tract infection(s) (uUTI) caused by certain bacteria (Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis) in adult women who have limited or no alternative oral antibacterial treatment options.

An uUTI is a bacterial bladder infection in women with no structural abnormalities of their urinary tract. Approximately one-half of all women will experience at least one uUTI in their lifetime, says the FDA.

"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," said Corey Fishman, Iterum's Chief Executive Officer, in a press release.

"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."

ORLYNVAH is a combination of sulopenem etzadroxil, a penem antibacterial, and probenecid, a renal tubular transport inhibitor, is indicated for the treatment of uUTI caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.

Orlynvah is taken as one oral tablet twice daily for 5 days but is not indicated for the primary or step-down treatment of complicated UTI (cUTI) or complicated intra-abdominal infections.

There are no available data on ORLYNVAH use in pregnant women to evaluate for a drug-associated risk of significant congenital disabilities, miscarriage, or adverse maternal or fetal outcomes.

Earlier in 2024, the FDA approved UTILITY therapeutics Ltd. Pivya™, a penicillin-class antibacterial tablet approved for treating female adults with uUTIs. Pivya is expected to be available in the U.S. in 2025. Pivya was previously approved in Canada, the United Kingdom, and other countries.

From a UTI prevention perspective, the Uromune™ (MV140) vaccine has been approved for adults in various countries, such as Mexico and the United Kingdom.

Uromune is an inactivated, oral spray, novel, sublingual mucosal-based bacterial vaccine that reduces recurrent UTIs. It is not FDA-approved and is unavailable in the U.S.