An oral penem antibiotic for women with uncomplicated urinary tract infections (uUTIs) has been launched by Iterum Therapeutics following its approval by the Food and Drug Administration last fall.
Orlynvah will be the first oral penem antibiotic in the U.S. and the first new branded treatment for uUTIs in 25 years, Iterum said in announcing the launch Aug. 20.
The FDA approved Orlynvah in October to treat uUTIs caused by E coli, Klebsiella pneumoniae or Proteus mirabilis for women with few or no oral antibiotic options. More than half of women with uncomplicated UTIs were resistant to at least one antibiotic and 13 percent, to three or more, a 2024 study found.
“The availability of ORLYNVAH is tremendous news for clinicians and patients alike,” said Marjorie Golden, MD, FIDSA, Site Chief, Infectious Disease, St. Raphael Campus Yale New Haven Hospital. “For patients who currently have limited treatment options, ORLYNVAH provides a long overdue oral alternative that allows for treatment in the community.”
Two clinical trials demonstrated Orlynvah’s effectiveness with women who had amoxicillin/clavulanate-susceptible pathogens and with ciprofloxacin-resistant pathogens.
The most common side effects were diarrhea, nausea, vaginal yeast infection, headache, and vomiting.