Shionogi seeks FDA approval for ensitrelvir COVID-19 prevention

** Shionogi & Co., Ltd. (TSE:4507) has commenced a rolling submission to the U.S. Food and Drug Administration (FDA) for a new drug application for ensitrelvir (Xocova®), an oral antiviral, as a post-exposure prophylactic treatment for COVID-19. This application is supported by positive results from the global Phase 3 SCORPIO-PEP trial, where ensitrelvir demonstrated effectiveness in preventing symptomatic COVID-19 following exposure. Ensitrelvir has already received Fast Track designation from the FDA for both treatment and post-exposure prophylaxis indications. If approved, ensitrelvir is expected to be the first oral option for COVID-19 post-exposure prevention.