GSK (GSK) announced that the Food and Drug Administration has approved a supplemental New Drug Application for gepotidacin as an oral option for adult and pediatric patients from 12 years of age weighing at least 45 kg who have limited or no alternative options for the treatment of uncomplicated urogenital gonorrhea caused by susceptible strains of Neisseria gonorrhoeae. “This milestone follows the US FDA approval of gepotidacin earlier this year as an oral treatment for female adult and pediatric patients 12 years of age and older with uncomplicated urinary tract infection,” the company stated. Tony Wood, Chief Scientific Officer, GSK, said: “We’re proud to have delivered the first new class of antibiotics for gonorrhea in over three decades and a new oral option for US patients. 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”.
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