¡New FDA approval for the treatment of
uncomplicated urinary tract infections (utis)!
Provides a crucial alternative to antimicrobial resistance
Octuber 31 2024
Urinary tract infections (UTIs) are some of the most common infections in clinical practice. Accurate diagnosis and evidence-based treatment of UTIs will lead to better clinical care for many patients and limit unnecessary use of antibiotics. Urinalysis and urine cultures are useful tools in the diagnosis of UTIs; however, it is important to recognize their limitations.
The FDA has approved Iterum Therapeutics’ Orlynvah (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (UTIs) in adult women with limited oral treatment options. Orlynvah is a novel, oral penem-type antibiotic effective against Enterobacterales species, including those that produce extended-spectrum beta-lactamases (ESBLs) or AmpC-type enzymes that cause resistance to third-generation cephalosporins.
This is Iterum’s first approved product and the first oral option of its kind in the United States, providing a crucial alternative against antimicrobial resistance in infections caused by Escherichia coli, Klebsiella pneumoniae and Proteus mirabilis.
According to Dr. Marjorie Golden, chief of the Division of Infectious Diseases at the St. Raphael Campus of Yale New Haven Hospital, the approval of Orlynvah represents “great news for those awaiting a new treatment option for at-risk patients.” Based on the clinical data generated, Orlynvah could become a significant alternative for the management of these infections in the community.
UTIs affect about 60% of women at some point in their lives, with recurrence ocurring in 40% of cases. Approximately 40 million prescriptions are written annually in the U.S., with 1% of infections showing resistance to common oral antibiotics. With an aging population and increasing antimicrobial resistance, Orlynvah offers an important option in the treatment of UTIs.