
FDA approves first new antibiotic to treat UTIs in nearly 3 decades
By Karah Rucker (Anchor), Shea Taylor (Producer), Shianne DeLeon (Video Editor)
- The FDA approved a new antibiotic to treat urinary tract infections in women and girls 12 and older. The company expects it to be available sometime in 2025.
- UTIs are becoming harder to treat as the bacteria that cause them become increasingly antibiotic-resistant.
- Nearly all bacteria that cause UTIs are resistant to at least one of the current medications used to treat the infections, and 8 in 10 are resistant to at least two.
Full Story
For the first time in nearly three decades, the Food and Drug Administration approved a new antibiotic for the treatment of urinary tract infections.
Media Landscape
See how news outlets across the political spectrum are covering this story. Learn moreBias Summary
- The U.S. Food and Drug Administration has approved Blujepa for treating uncomplicated urinary tract infections in women and children aged 12 years and older who weigh 88 pounds or more.
- Clinical trials showed that Blujepa demonstrated therapeutic success in 50.6% of patients compared to 47.0% for nitrofurantoin in EAGLE-2.
- Common side effects of Blujepa include diarrhea in 16% of patients and gastrointestinal issues, with most adverse events being mild or moderate.
- Tony Wood, chief scientific officer of GlaxoSmithKline, stated that Blujepa is a crucial milestone for treating recurrent UTIs.
- On March 25, the U.S. Food and Drug Administration approved Blujepa, a new oral antibiotic developed by GSK, to treat uncomplicated urinary tract infections in females 12 and older.
- Recurrent UTIs have become a growing concern due to increasing antibiotic resistance, with approximately half of all women experiencing a UTI in their lifetime and about 30% experiencing a recurrence after treatment.
- Blujepa represents the first new class of oral antibiotics for UTIs in nearly three decades, offering a targeted mechanism of action that may reduce the likelihood of bacterial resistance compared to frontline antibiotics like nitrofurantoin, and performed as well as or better than nitrofurantoin in clinical trials.
- Dr. Tony Wood, GSK's chief scientific officer, stated that Blujepa's approval is a crucial milestone, emphasizing its potential to provide another option for patients facing recurrent infections and rising antibiotic resistance.
- Clinical trials involving over 3,000 women and teen girls showed that common side effects of Blujepa included diarrhea and nausea , while the US government's Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency partially funded Blujepa's development.
- The U.S. Food and Drug Administration has approved Blujepa for treating uncomplicated urinary tract infections in women and children aged 12 years and older weighing 88 pounds or more.
- Approval was based on phase 3 EAGLE-2 and EAGLE-3 trials, showing Blujepa's superiority over nitrofurantoin, with therapeutic success rates of 58.5% versus 43.6%.
- The most common side effects reported include gastrointestinal issues, with diarrhea occurring in 16% of patients and nausea in 9%.
- GSK plans to launch Blujepa in the U.S. In the second half of the year, aiming for peak sales of over 2 billion pounds.
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What do we know about this new treatment?
The company will sell the medicine as a pill under the brand name Bluejepa. The FDA approved the drug for women and girls older than 12 to treat uncomplicated UTIs.
Uncomplicated UTIs are those caused by bacteria and are the most common form of infection.

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Why is this a big deal?
UTIs are becoming harder to treat as the bacteria that cause them become more resistant to the antibiotics currently available to treat them.
The drug’s maker, GSK, said about half of all women will experience a UTI in their lifetime. The company also stated that nearly 30% of women will experience a recurrence even after treatment.
According to the company, UTIs are the cause of roughly 8 million emergency room visits and 100,000 hospitalizations each year in the United States.
GSK’s chief scientific officer said this new medication may be harder for bacteria to become resistant to, as it works by interfering with two enzymes that bacteria need to copy themselves.
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A 2019 study out of Saudi Arabia’s Qassim University found more than 92% of bacteria that cause UTIs are resistant to at least one drug used to treat them, and about 80% are resistant to at least two.
When will it be available?
Blujepa is expected to be available by the second half of 2025.
[Karah Rucker]
FOR THE FIRST TIME IN NEARLY THREE DECADES – THE FOOD AND DRUG ADMINISTRATION HAS APPROVED A NEW ANTIBIOTIC FOR THE TREATMENT OF URINARY TRACT INFECTIONS.
THE MEDICINE – A PILL WHICH WILL BE SOLD UNDER THE BRAND NAME BLUJEPA – IS EXPECTED TO BE AVAILABLE BY THE SECOND HALF OF **THIS** YEAR.
IT’S BEEN APPROVED BY THE F-D-A FOR WOMEN AND GIRLS 12 AND OLDER TO TREAT U-T-Is CAUSED BY BACTERIA – THE MOST COMMON FORM OF THE INFECTION.
U-T-Is ARE BECOMING A MORE COMMON PROBLEM AS THE BACTERIA THAT CAUSE THEM BECOME MORE RESISTANT TO THE ANTIBIOTICS CURRENTLY AVAILABLE TO TREAT THEM.
THE DRUG’S MAKER – G-S-K – SAYS ABOUT HALF OF ALL WOMEN WILL EXPERIENCE A U-T-I IN THEIR LIFETIME…
AND NEARLY A THIRD WILL HAVE ONE THAT COMES BACK EVEN AFTER BEING TREATED.
THEY ALSO SAY U-T-Is ARE THE CAUSE OF ROUGHLY 8 MILLION EMERGENCY ROOM VISITS AND 100-THOUSAND HOSPITALIZATIONS EACH YEAR IN THE UNITED STATES.
G-S-K’S CHIEF SCIENTIFIC OFFICER SAYS THIS NEW MEDICATION **MAY** BE HARDER FOR BACTERIA TO BECOME RESISTANT TO – AS IT WORKS BY INTERFERING WITH TWO ENZYMES THAT BACTERIA NEED TO COPY THEMSELVES.
A 20-19 STUDY OUT OD SAUDI ARABIA’S QASSIM (KAH-sim) UNIVERSITY FOUND MORE THAN 92 PERCENT OF BACTERIA THAT CAUSE U-T-Is ARE RESISTANT TO AT LEAST ONE DRUG USED TO TREAT THEM… AND ABOUT 80 PERCENT ARE RESISTANT TO AT LEAST TWO.
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Media Landscape
See how news outlets across the political spectrum are covering this story. Learn moreBias Summary
- The U.S. Food and Drug Administration has approved Blujepa for treating uncomplicated urinary tract infections in women and children aged 12 years and older who weigh 88 pounds or more.
- Clinical trials showed that Blujepa demonstrated therapeutic success in 50.6% of patients compared to 47.0% for nitrofurantoin in EAGLE-2.
- Common side effects of Blujepa include diarrhea in 16% of patients and gastrointestinal issues, with most adverse events being mild or moderate.
- Tony Wood, chief scientific officer of GlaxoSmithKline, stated that Blujepa is a crucial milestone for treating recurrent UTIs.
- On March 25, the U.S. Food and Drug Administration approved Blujepa, a new oral antibiotic developed by GSK, to treat uncomplicated urinary tract infections in females 12 and older.
- Recurrent UTIs have become a growing concern due to increasing antibiotic resistance, with approximately half of all women experiencing a UTI in their lifetime and about 30% experiencing a recurrence after treatment.
- Blujepa represents the first new class of oral antibiotics for UTIs in nearly three decades, offering a targeted mechanism of action that may reduce the likelihood of bacterial resistance compared to frontline antibiotics like nitrofurantoin, and performed as well as or better than nitrofurantoin in clinical trials.
- Dr. Tony Wood, GSK's chief scientific officer, stated that Blujepa's approval is a crucial milestone, emphasizing its potential to provide another option for patients facing recurrent infections and rising antibiotic resistance.
- Clinical trials involving over 3,000 women and teen girls showed that common side effects of Blujepa included diarrhea and nausea , while the US government's Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency partially funded Blujepa's development.
- The U.S. Food and Drug Administration has approved Blujepa for treating uncomplicated urinary tract infections in women and children aged 12 years and older weighing 88 pounds or more.
- Approval was based on phase 3 EAGLE-2 and EAGLE-3 trials, showing Blujepa's superiority over nitrofurantoin, with therapeutic success rates of 58.5% versus 43.6%.
- The most common side effects reported include gastrointestinal issues, with diarrhea occurring in 16% of patients and nausea in 9%.
- GSK plans to launch Blujepa in the U.S. In the second half of the year, aiming for peak sales of over 2 billion pounds.
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Bias Distribution
Left
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