The Food and Drug Administration (FDA) has approved a new drug for treating urinary tract infections, the first such drug approved in decades and the first in a new class of medications.
British pharmaceutical company GSK announced Tuesday that the FDA had approved its oral antibiotic Blujepa for treating uncomplicated urinary tract infections (UTIs) in female adults and pediatric patients 12 and older.
A UTI is considered uncomplicated if it occurs in a female individual who does not have a fever, is pregnant, does not have a condition that weakens their immune system, does not have a catheter in place and the UTI is limited to the lower part of the urinary tract.
According to the drugmaker, Blujepa works through a novel mechanism, inhibiting bacterial DNA replication. A U.S. commercial launch is planned for the second half of 2025. Funds from the Department of Health and Human Services, Administration for Strategic Preparedness and Response and the Biomedical Advanced Research and Development Authority went to the development of Blujepa.
The drug is effective against UTIs caused by E. coli, Klebsiella, Citrobacter freundii, Staphylococcus saprophyticus and Enterococcus faecalis. The most common side effects reported from using the drug were gastrointestinal issues, including diarrhea and nausea.
“The approval of Blujepa is a crucial milestone with uUTIs among the most common infections in women,” Tony Wood, GSK’s chief scientific officer, said in a statement. “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.”
