Novel antibiotic, Gepotidacin tablets, has received FDA approval for a new indication.
?According to news reports from London, UK, pharmaceutical company GlaxoSmithKline (GSK) announced that the US Food and Drug Administration (FDA) has approved its supplemental new drug application for the novel oral antibiotic 750mg Gepotidacin tablets (brand name: "Blujepa"). This oral treatment is indicated for uncomplicated urethral and genital gonorrhea caused by susceptible Neisseria gonorrhoeae in adult and pediatric patients aged 12 years and older and weighing at least 45 kg, where treatment options are limited or non-existent.
According to news reports from London, UK, pharmaceutical company GlaxoSmithKline (GSK) announced that the US Food and Drug Administration (FDA) has approved its supplemental new drug application for the novel oral antibiotic 750mg Gepotidacin tablets (brand name: "Blujepa"). This oral treatment is indicated for uncomplicated urethral and genital gonorrhea caused by susceptible Neisseria gonorrhoeae in adult and pediatric patients aged 12 years and older and weighing at least 45 kg, where treatment options are limited or non-existent.
GSK scientists discovered that Gepotidacin is a novel bactericidal triaza-naphthyridine class antibiotic that inhibits bacterial DNA replication through a unique binding site, featuring a novel mechanism of action. For most pathogens, it provides balanced inhibition of two different type II topoisomerases. This product is active against Neisseria gonorrhoeae and most urinary tract pathogens (such as Escherichia coli and Streptococcus pyogenes), including strains resistant to current antibiotics. Due to Gepotidacin's good balanced antibacterial activity against most pathogens, single-target specific mutations may not significantly affect its activity.
Moreover, Gepotidacin's antimicrobial spectrum primarily targets Escherichia coli-like bacteria. This means that, compared to broad-spectrum antibiotics, its potential to induce bacterial resistance is lower. GSK expects that Gepotidacin could achieve peak annual sales of up to ￡2 billion (approximately $2.6 billion) in the future.