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FDA approves new oral antibiotic bluzepa for UTI treatment in women and adolescents
The FDA has approved Blujepa (Gepotidacin), which is a first-in-in-class oral antibiotic for incomplete urinary tract infections (UUTI) in women and children aged 12 and older. Clinical trials showed their effectiveness against antibiotic-resistant bacteria.

FDA approves new oral antibiotic bluzepa for UTI treatment in women and adolescents (image credit: istock)
The US Food and Drug Administration (FDA) has approved a novel oral antibiotic, Bluezepa (Gepotidasin), a novel for the treatment of adult women and incomplete urinary tract infections (UUTI) in children aged 12 and above, which weighs 40 kg or more. This approval is a significant success in the fight against Uuti, especially given the increasing antibiotic resistance associated with existing treatments.
Blujepa is the first-in-in-class oral antibiotic, developed to combat utis due to various bacterial pathogens, including Eschherichia coli, Clabciella Pneumonia, Citrobacter Fundi Complex, Staphylococcus Sapophiticus and Entrococcus Facolis. Glaxosmithkline was approved after promising results from two phases 3 clinical trials, Eagle -2 and Eagle -3.
Clinical test success
Bluezepa’s efficacy was displayed in these massive trials, comparing its effectiveness against nitrophurantin, which was widely used antibiotic for UUTI. Eagle -2 studies found that 50.6 percent of patients taking Bluezepa were medical success, while compared to 47.0 percent treated with nitrophurantin. Meanwhile, the Eagle -3 test showed the superiority of the Bluejepa, with 58.5 percent of the patients with medical success, while in the nitrophurantoin group compared to just 43.6 percent.While Blujepa was usually well tolerated, some participants lightly reported to the moderate gastrointestinal side effects, including diarrhea (16 percent) and nausea (9 percent). Severe gastrointestinal issues were rare, which were less than 1 percent of patients. Each treatment in the tests was reported to be an adverse incident related to a serious drug in the hand.
Explaining the importance of this approval, Tony Wood, Chief Scientific Officer of GSK, said, “Bluejepa’s approval is an important milestone, with Utis among the most common infections in women.
What are urinary tract infections?
Urinary tract infections are among the most prevalent bacterial infections, especially affecting women. Symptoms of a UTI include:- A strong, persistent urge to urinate
- A burning sensation while urinating
- Continuous, small amount of urine
- Cloud, dark, or strong urine
- Pelvic pain in women, especially around the lower abdomen
If left untreated, uutis can lead to more severe kidney infection, causing fever, chills, nausea and back pain.
Alternative treatment and prevention
While antibiotics such as Blujepa are a primary aid for uti, many other approaches can help manage or prevent these infections:- Halid: Drinking lots of water helps in flushing bacteria from the urinary tract.
- Cranberry supplements: Some studies suggest that cranberry products can help prevent UTIs by preventing bacteria on the bladder wall.
- Probiotics: Lactobacillus-based probiotics can support a healthy urinary microbiom and reduce recurrence.
- Cleanliness practice: Wiping from back to back and urinating after intercourse can help prevent the spread of bacteria.
Blujepa approval provides a promising new option for patients, especially those having those recurrent infections or resistance to existing antibiotics.
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