The FDA approved gepotidacin (Blujepa), an oral option for the treatment of uncomplicated urogenital gonorrhea among patients ages 12 years and older, GSK announced on Thursday.
Gepotidacin is the first in a new class of antibiotics for the treatment of gonorrhea approved in over three decades, with activity against Neisseria gonorrhoeae and uropathogens such as Escherichia coli and Staphylococcus saprophyticus. The FDA approved the drug in May to treat uncomplicated urinary tract infections in women and girls ages 12 years and up.
“The ability of N. gonorrhoeae to develop resistance to currently available options, including standard of care, makes it important to expand the range of effective oral treatments,” said Tony Wood, PhD, GSK’s chief scientific officer.
The approval was based on results from the randomized phase III EAGLE-1 trial, which compared two doses of oral gepotidacin with intramuscular ceftriaxone plus oral azithromycin in participants with a clinical suspicion of uncomplicated urogenital gonorrhea.
Among 406 patients, the microbiological success rate was 92.6% with gepotidacin compared with 91.2% with ceftriaxone plus azithromycin. The adjusted treatment difference between the gepotidacin and dual-therapy groups was -0.1% (95% CI -5.6 to 5.5), falling within the prespecified criteria for noninferiority (a lower CI limit above -10.0%).
Among the 622 participants in the safety population — all randomized patients who received at least one dose of study treatment — those in the gepotidacin group reported a substantially higher number of adverse events compared with those in the dual-therapy arm (519 vs 141 events). Mild-to-moderate gastrointestinal adverse effects — primarily diarrhea — were frequent in the gepotidacin group.
The FDA said that patients taking gepotidacin must weigh at least 45 kg and have limited or no alternative treatment options (e.g., where standard of care is contraindicated, or where patients are intolerant or unwilling to use first-line treatment).
According to the World Health Organization, there were an estimated 82.4 million new gonorrhea infections among adults across the globe in 2020. If left untreated, gonorrhea can cause a variety of sexual and reproductive health complications, including infertility in both men and women. It also increases the risk of HIV infection.
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