Shionogi & Co. has received FDA approval for Xocova (ensitrelvir), the first oral antiviral to prevent symptomatic COVID-19 after contact with an infected individual.
Xocova is a SARS-CoV-2 main protease inhibitor that acts as a post-exposure prophylaxis (PEP) for adults and pediatric patients aged 12 and above. It works by blocking viral replication following exposure but before symptoms begin. In the phase 3 SCORPIO-PEP trial, Xocova led to a reduced risk of symptomatic COVID-19 of 67% from exposure to day 10 compared to a placebo. Adverse events occurred at similar rates in patients taking Xocova and those in the placebo group.
Approval for Xocova for PEP in the U.S. comes before the PDUFA action date of June 16, 2026. The medication has also had full approval for treatment of COVID-19 in Japan since March 2024, based on the SCORPIO-SR phase 3 trial carried out in Asia. This followed emergency regulatory approval in Japan for treatment of COVID-19 in November 2022.