The US Food and Drug Administration (FDA) has early this week approved GSK's new antibiotic, Blujepa (gepotidacin), for the treatment of uncomplicated urinary tract infections (UTIs) in women aged 12 years and older. UTIs, which are commonly caused by bacteria such as E. coli, are frequent in women, with over half of women experiencing an uncomplicated UTI in their lifetime, and around 30% suffering from recurrent episodes.
Currently, the most common treatment for uncomplicated UTIs in women is nitrofurantoin, an antibiotic that has been in use since the 1950s. Other options include trimethoprim-sulfamethoxazole and fosfomycin. These antibiotics are effective in treating uncomplicated UTIs caused by bacteria like E. coli, but their effectiveness is increasingly threatened by antimicrobial resistance (AMR). AMR occurs when bacteria evolve to resist the drugs designed to kill them, rendering treatments like nitrofurantoin less effective over time.
According to medical journal reviews, Blujepa acts differently from most antibiotics, targeting a specific part of the bacteria and reducing the risk of bacterial resistance. This innovative approach helps combat the growing issue of antimicrobial resistance (AMR), which causes millions of infections annually worldwide.
The US FDA approval review states that permission for GSK's new drug was supported by data from two late-stage clinical trials, where gepotidacin showed superior efficacy to nitrofurantoin, the standard treatment for uncomplicated UTIs since the 1950s. In one trial, 58.5% of patients treated with gepotidacin experienced complete disease resolution, compared to 43.6% for nitrofurantoin. The company plans to launch the drug in the US in the second half of the year.
"This new drug, based on the studies I've reviewed, could help address some of the critical challenges we face in treating common UTIs with the current regimen, such as the declining efficacy of existing antibiotics due to bacterial resistance and other functional barriers," says a noted urologist Roy K Mathew.
Comparison of Current UTI Treatment Regime vs. Blujepa
Gepotidacin (Blujepa), however, offers a new mechanism of action, says FDA approval documents. It targets bacterial enzymes differently from current antibiotics, which not only makes it effective against E. coli but also less likely for the bacteria to develop resistance to the drug.
In clinical trials, Blujepa showed superior outcomes compared to nitrofurantoin, with a higher percentage of patients achieving complete resolution of their infection. This makes it a promising option in combating UTIs, particularly as resistance to older drugs continues to rise.
In addition to gepotidacin, another newer antibiotic, Orlynvah, has been approved for UTIs by Iterum Therapeutics, adding further competition in the UTI treatment space. Despite this, GSK's approach with Blujepa, combined with its effectiveness against resistant bacteria, places it as a strong contender in the evolving landscape of UTI treatment.