GSK said the U.S. Food and Drug Administration approved its Blujepa oral antibiotic for the treatment of female adults and children with uncomplicated urinary tract infections.
The pharmaceutical company said Tuesday that the drug will be able to be used against urinary tract infections caused by the microorganisms Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis.
Blujepa is the first in a new class of oral antibiotics for uncomplicated urinary tract infections approved in nearly 30 years, GSK's Chief Scientific Officer Tony Wood said.
These infections are most common among women, affecting about 16 million of them in the U.S. annually.
The drug manufacturer expects to launch Blujepa in the U.S. in the second half of this year.
The FDA's approval is based on positive results from the phase III Eagle-2 and Eagle-3 trials, which demonstrated non-inferiority to nitrofurantoin, one of the leading current standard-of-care options for these infections, GSK said.
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