The US Food and Drug Administration approved Shionogi & Co's (TYO:4507) Xocova or ensitrelvir as the first and only oral antiviral for post-exposure prophylaxis of COVID-19 in individuals aged 12 and older, according to a Tokyo bourse filing on Monday.
The approval, which came ahead of the June 16 Prescription Drug User Fee Act action date, was supported by Phase 3 Scorpio-PEP trial results, which showed a 67% reduction in symptomatic COVID-19 risk following exposure compared to placebo.
The treatment was generally well tolerated, with adverse event rates similar to placebo, and no reports of altered taste attributed to the drug.