HQ Team
March 26, 2025: The US Food and Drug Administration has approved Britain’s GSK Plc’s drug to treat urinary tract infections in adult women and girls above 12 years, according to the company.
The approval was based on data from end-stage trials of Blujepa — an oral antibiotic for the treatment of uncomplicated urinary tract infections (uUTIs), according to a company statement. The drug is planned to be unveiled in the US by the second half of this year.
The trials yielded positive results demonstrating “non-inferiority to nitrofurantoin, one of the leading current standard of care options for uUTI, in female adults (greater or equal to 40 kg) and paediatric patients (more than 12 years, and above 40 kg) with a confirmed uUTI,” according to the statement.
50% of women get infected
Therapeutic success occurred in 58.5% of more than 250 participants compared to 43.6% for nitrofurantoin. The safety and tolerability of the drug was consistent with previous trials.
Nitrofurantoin, sold under the brand name Macrobid, among others, is an antibacterial medication of the nitrofuran class used to treat urinary tract infections, although it is not as effective for kidney infections. It is taken by mouth. Common side effects include nausea, loss of appetite, diarrhoea, and headaches.
Blujepa treats women infected with Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, staphylococcus saprophyticus and Enterococcus faecalis. It is the first in a new class of oral antibiotics for uUTIs in nearly 30 years, according to GSK.
Over half of all women experience a uUTI in their lifetime, with approximately 30% suffering from recurrent episodes. About 1 in 10 men will get a UTI in their lifetime. Children can get UTIs as well, though this is rare – about 1 or 2 in 100.
‘Crucial milestone’
‘“The approval of Blujepa is a crucial milestone with uUTIs among the most common infections in women,” said Tony Wood, Chief Scientific Officer, GSK. “We are proud to have developed Blujepa, the first in a new class of oral antibiotics for uUTIs in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments.”
Uncomplicated UTIs are the most common infection in women, impacting up to 16 million women in the US annually.
It can cause significant patient burden, including discomfort and restriction of daily activities. New treatments are needed as the number of uUTIs caused by drug-resistant bacteria is increasing which can result in higher treatment failure rates.
Recurrent infections
“For many, uUTIs can be a burden that severely impacts daily life. With an increasing number of patients experiencing recurrent infections, there remains a clear need for continued research of antimicrobials to help address ongoing patient challenges and the strain on healthcare systems,” said Thomas Hooton, MD, Professor of Clinical Medicine, University of Miami School of Medicine.
The most commonly reported adverse event of using Blujepa was gastrointestinal, with diarrhoea being the most common among the participants in the trial, followed by nausea.
