GSK has received approval from the U.S. Food and Drug Administration (FDA) for Blujepa, a new antibiotic for treating uncomplicated urogenital gonorrhea. This marks the first approval of a new class of antibiotics for this infection in over 30 years.
The FDA’s decision allows Blujepa to be prescribed to patients aged 12 and older who weigh at least 45 kilograms and have limited or no alternative treatment options. The drug is only indicated for cases caused by Neisseria gonorrhoeae strains that are susceptible to Blujepa.
According to the Centers for Disease Control and Prevention, there are approximately 1.57 million new cases of gonorrhea annually in the United States, making it the second most common sexually transmitted infection in the country. The emergence of antibiotic-resistant N. gonorrhoeae strains has complicated treatment, as many no longer respond to commonly used antibiotics like cefixime, ceftriaxone, and azithromycin. Currently, there are no approved vaccines against gonorrhea.
The FDA’s approval was supported by data from the Phase III EAGLE-1 clinical trial. In this study, Blujepa demonstrated a success rate of 92.6% among treated patients compared with 91.2% in those receiving standard therapy—a combination of intramuscular ceftriaxone and oral azithromycin. GSK reported that “the Blujepa arm also saw no treatment failures at the urogenital site due to bacterial persistence,” and noted that “the antibiotic triggered no serious drug-related toxicities.”
Blujepa is administered orally and belongs to a novel class called triazaacenaphthylenes, which work by targeting type II topoisomerases involved in bacterial DNA replication. According to GSK, “no clear mechanisms of resistance” have been identified so far.
Earlier this year in March, Blujepa received its initial approval for use in female patients aged 12 years or older weighing at least 40 kilograms with uncomplicated urinary tract infections caused by several bacteria including Escherichia coli and Klebsiella pneumoniae.
In related news within infectious disease treatments, Assembly Biosciences recently announced positive results from early-stage studies on two oral herpes drugs—ABI-1179 and ABI-5366—which reduced viral shedding and lesion rates compared to current therapies. Guggenheim Partners described these investigational antivirals as “strong candidates with both differentiated efficacy and more favorable dosing vs. standard of care.” In addition, Merck recently completed its $9.2 billion acquisition of Cidara Therapeutics centered on late-stage antiviral therapies for influenza.
