The U.S. Food and Drug Administration (FDA) has approved Blujepa, an innovative oral antibiotic for treating uncomplicated urinary tract infections (uUTIs) in women and children. This approval comes at a critical time as uUTIs caused by drug-resistant bacteria continue to rise, leading to higher rates of treatment failure.
Blujepa, developed by GSK, is the first oral antibiotic in a new class for uUTIs in nearly 30 years. It works with a novel mechanism of action and is specifically designed to target infections caused by Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis.
Tony Wood, GSK’s Chief Scientific Officer, emphasized the importance of this approval in a press release on March 25, 2025. He noted, “uUTIs are among the most common infections in women, and Blujepa represents a significant step forward in our ability to treat them.”
uUTIs affect up to 16 million women in the U.S. each year. More than half of women will experience at least one uUTI in their lifetime, with approximately 30% suffering from recurrent infections. These episodes can lead to discomfort and limit daily activities, making effective treatment crucial.
In addition to Blujepa, two other treatments have been approved for uUTIs. Pivya™ (Pivmecillinam), an extended-spectrum penicillin, is used in Europe. It targets the cell wall of gram-negative bacteria. In the U.S., ORLYNVAH™ is a novel oral penem antibiotic approved for uUTIs caused by Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis in adult women.
While oral vaccines for uUTIs, such as Uromune™ (MV140), are available in other countries, they remain unavailable in the U.S. as of 2025.
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