IN BRIEF: GSK says US FDA backs supplemental gepotidacin application
GSK PLC - London-based pharmaceuticals firm - US Food & Drug Administration approves a supplemental new drug application for gepotidacin as an oral option for adult and paediatric patients from 12 years of age for the treatment of uncomplicated urogenital gonorrhoea. This 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 with uncomplicated urinary tract infection. The application was based on positive results from the Eagle-1 phase III trial which demonstrated that gepotidacin was non-inferior to standard of care combination treatment for gonorrhoea. The trial also supported the safety and tolerability profile of gepotidacin, with no serious drug related adverse events observed in either the gepotidacin or the comparator arm. The most common reported adverse reactions were mild to moderate gastrointestinal events. Read More