Blujepa is also approved for uncomplicated urinary tract infection in females 12 years and older.
The FDA has cleared the use of GSK’s Blujepa for the treatment of uncomplicated urogenital gonorrhea, unlocking the first new type of antibiotic for the infection in more than three decades.
With the approval, announced Thursday, Blujepa can now be used in patients 12 years and older who weigh at least 45 kg, and for whom there are limited or no alternative treatment options. Blujepa can only be used in patients whose infections are caused by susceptible Neisseria gonorrhoeae strains.
With around 1.57 million new cases in the U.S. per year, gonorrhea is an urgent public health threat and is the second most prevalent sexually transmitted infection in the country, according to the CDC. Many strains of N. gonorrhoeae have grown resistant to common antibiotics, such as cefixime, ceftriaxone and azithromycin, complicating treatment decisions. There are currently no licensed vaccines to prevent gonorrhea.
Supporting the FDA’s decision on Thursday are data from the Phase III EAGLE-1 study, which demonstrated a 92.6% success rate in patients treated with Blujepa, as compared with 91.2% in comparators given a combination of intramuscular ceftriaxone and oral azithromycin. The Blujepa arm also saw no treatment failures at the urogenital site due to bacterial persistence, GSK said in an August news release, adding that the antibiotic triggered no serious drug-related toxicities.
Taken orally, Blujepa is a first-in-class antibacterial drug classified as a triazaacenaphthylene. It works by targeting and disrupting the action of type II topoisomerases, which bacteria use to replicate their DNA. GSK has identified no clear mechanisms of resistance to Blujepa yet, according to the drug’s label.
Blujepa was first approved in March this year, opening its use for uncomplicated urinary tract infection in female patients 12 years and older weighing at least 40 kg. That approval covers infections caused by Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis.
Thursday’s label expansion comes after Assembly Biosciences scored a key victory in the infectious disease space. On Monday, Assembly reported that its oral herpes drugs—the weekly ABI-1179 and the monthly ABI-5366—strongly reduced viral shedding and lowered genital lesion rates in two Phase I studies. Reacting to the data, Guggenheim Partners on Monday called the investigational antivirals “strong candidates with both differentiated efficacy and more favorable dosing vs. standard of care.”
A few weeks earlier, Merck infused the infectious disease space with $9.2 billion via its acquisition of Cidara Therapeutics, a deal anchored by the California biotech’s late-stage antiviral for flu.
