GSK press release
11 December 2025 — GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application for gepotidacin as an oral option for adult and paediatric patients from 12 years of age weighing at least 45 kg who have limited or no alternative options for the treatment of uncomplicated urogenital gonorrhoea caused by susceptible strains of Neisseria gonorrhoeae (e.g., where standard of care is contraindicated, or where patients are intolerant or unwilling to use first line treatment). This milestone follows the US FDA approval of gepotidacin earlier this year as an oral treatment for female adult and paediatric patients 12 years of age and older (weighing ≥40 kg) with uncomplicated urinary tract infection.
Gonorrhoea is a common, sexually transmitted infection caused by Neisseria gonorrhoeae, which has been recognised by the World Health Organization as a priority pathogen and an urgent public health threat by the US Centers for Disease Control and Prevention (CDC).
Read the full company press release here.
Source : GSK
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