25th Mar 2025 18:30
(Alliance News) - GSK on Tuesday said its urinary tract infection treatment gepotidacin, under the brand name Blujepa, has been approved in the US.
The London-based pharmaceuticals company said the US Food and Drug administration has approved Blujepa for the treatment of uncomplicated UTIs in female adults and paediatric patients 12 years of age and older.
GSK said the drug is the first in a new class of oral antibiotics for uncomplicated UTIs in almost 30 years.
The approval is based on data from the pivotal phase three Eagle-2 and Eagle-3 trials.
The company said the commercial launch in the US is planned for the second half of 2025.
"The approval of Blujepa is a crucial milestone with uUTIs among the most common infections in women," said Chief Scientific Officer Tony Wood.
"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."
GSK shares closed up 0.1% at 1,486.00 pence in London on Tuesday afternoon.
By Michael Hennessey, Alliance News reporter
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