Women and girls with urinary tract infections (UTIs), especially stubborn ones that tend to recur despite treatment, have a new medication option now that the U.S. Food and Drug Administration (FDA) has approved the oral antibiotic gepotidacin.
“The new antibiotic is a fantastic event, as there is a significant minority of women with UTIs that have become resistant to the current armamentarium of antibiotics. This gives an option to those who would otherwise need intravenous antibiotics,” says Craig Comiter, MD, a professor of urology and urologist at Stanford Health Care in California.
Blujepa Approval Provides ‘Another Important Choice’ for UTI Treatment
Blujepa’s approval is based on positive outcomes from two late-stage clinical trials, EAGLE-2 and EAGLE-3. In these studies, Blujepa was compared with nitrofurantoin, a leading treatment for uncomplicated UTIs.
In the EAGLE-2 trial, Blujepa demonstrated non-inferiority, meaning it was at least as effective as nitrofurantoin, and 50 percent of the women were symptom free and had no microbiological signs of infection, compared with 47 percent for nitrofurantoin.
Bluejepa appears to be about as effective as the currently available options, says Dr. Comiter. “But when bacteria are resistant to other antibiotics, choices are limited, and so this gives us another important choice,” says Comiter.
What Are the Side Effects of Blujepa?
Blujepa was generally well tolerated in the clinical trials. As is typical with antibiotics, gastrointestinal side effects were the most common. Diarrhea topped the list, occurring in 14 to 18 percent of participants. Nausea was also noted, at close to 9 percent.
UTIs Increasingly Involve Drug-Resistant Bacteria
UTIs, also called bladder infections, are most often caused when bacteria that are typically found in the digestive tract migrate to the urinary tract during sex or while wiping after a bowel movement.
- A strong urge to urinate that doesn’t go away
- Burning and painful urination
- Cloudy, red, or pink urine
- Pelvic pain
Evidence suggests that more than 90 percent of bacteria that cause UTIs are resistant to at least one common antibiotic, and almost 80 percent are resistant to at least two.
That’s why new antibiotics are necessary, explains Comiter. “Resistance is acquired, generally ascribed to overuse of antibiotics, but it is a natural part of bacterial evolution and may be unavoidable,” he says.
Blujepa will be most appropriate for people with UTIs caused by resistant bacteria, commonly called ESBL (extended spectrum beta-lactamase) or MDR (multidrug resistant) strains, says Comiter.
“This approval will also help patients everywhere who have multiresistant infection,” he says.
When Will Blujepa Be Available and How Much Will It Cost?
Blujepa is expected to be available in the United States sometime this summer, says Lyndsay Meyer, the director of U.S. Corporate Media Relations at GSK.
“Details are forthcoming,” on how much a round of the antibiotic will cost and insurance coverage, she says.
Given that most antibiotics are generic, and Blujepa will be a new branded option, will cost be a consideration in prescribing to patients?
“Cost is always a consideration, and this treatment should be ‘saved’ for those bacteria that are known to be resistant to current antibiotics,” says Comiter.