Overview

• Authorization covers females aged 12 and older who weigh at least 40kg.
• The decision is based on two randomized Phase III trials showing similar effectiveness to nitrofurantoin, with 1,572 patients on gepotidacin and 1,564 on the comparator.
• The medicine blocks two bacterial enzymes required for replication, which the regulator says could reduce the chance of resistance developing.
• The recommended regimen is two tablets approximately every 12 hours for five days, with mild nausea and diarrhoea reported as the most common side effects.
• The UK clearance follows FDA approval in March, with ongoing safety monitoring planned and a NICE appraisal required for routine NHS use.