Dive Brief:

• The Food and Drug Administration on Tuesday cleared a new kind of oral antibiotic for the treatment of common urinary tract infection in women and girls 12 years or older.
• The oral drug gepotidacin, which its maker GSK will sell as Blujepa, is approved to treat uncomplicated urinary tract infections caused by five common types of bacteria, including E. coli.
• More antibiotic options are needed as the threat of microbial resistance to drugs grows. GSK, which plans to launch Blujepa in the second half of this year, expects a lower risk of resistance due to how its drug works.

Dive Insight:

Blujepa’s approval was based on results from two Phase 3 trials involving some 3,000 women and girls who were randomized to receive either twice-daily Blujepa or nitrofurantoin, a common antibiotic prescribed for UTIs.

Results showed that, in one, Blujepa was “non-inferior” to nitrofurantoin in resolving symptoms and reducing pathogen levels and, in the other, “superior” to that drug on the same measure. Results were published in the medical journal The Lancet last year.

Blujepa is what’s known as a triazaacenaphthylene antibiotic. It works by hampering bacterial DNA replication via inhibition of two enzymes. It’s cleared to treat infections caused by E. coli as well as Staphylococcus saprophyticus, Klebsiella pneumoniae, Citrobacter freundii complex and Enterococcus faecalis.

The drug has also shown promise for treating the bacterial infection gonorrhea. While treatment options exist for the infection, cases have risen in the U.S. and there is increasing resistance to available medicines. GSK said last year the antibiotic succeeded in a late-stage trial and plans to seek approval in that indication as well.

GSK scientists discovered the drug, which was developed in part through the support of the U.S. Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency.