“The FDA recently approved ensitrelvir (Xocova; Shionogi), an anti–SARS-CoV-2 oral drug for postexposure prophylaxis (PEP) of COVID-19, for adults and adolescents 12 years of age and older.1 Ensitrelvir is now approved in the US and Japan for PEP against COVID-19 for individuals in this age group who have had contact with someone who has COVID-19.
The approval was based on evidence from the global phase 3 clinical trial SCORPIO-PEP (NCT05897541), which demonstrated favorable safety and efficacy in uninfected pediatric and adult patients who had been exposed to an infected individual, reducing the risk of symptomatic COVID-19 by 67%. The agent, which was also approved in Japan in March 2024 to treat COVID-19 based on results from the SCORPIO-SR phase 3 study, is now the first and only oral PEP option for COVID-19 and could help combat declining vaccination rates, waning immunity, and emerging strains of COVID-19.”
