The FDA has approved Xocova (ensitrelvir) for post-exposure prophylaxis of COVID-19 in adults and adolescents age 12 and older following contact with an individual who has COVID-19.
The approval makes Xocova the first and only oral option to help prevent COVID-19 after exposure, according to a June 1 news release. The five-day regimen consists of three tablets on Day 1 and one tablet daily on Days 2-5.
The approval was based on results from Shionogi’s phase 3 Scorpio-Pep trial, which Shionogi said was the only phase 3 study of an oral antiviral to meet its primary endpoint for preventing symptomatic COVID-19 following exposure to an infected individual. In the study, Xocova reduced the risk of symptomatic COVID-19 by 67% through Day 10 compared with placebo among uninfected individuals following exposure.
The company said adverse event rates were similar between treatment groups, occurring in 15.1% of participants who received Xocova and 15.5% of those who received placebo. The most common adverse events reported more frequently with Xocova were headache, diarrhea and cough.
The FDA completed its review two weeks ahead of the June 16 PDUFA deadline — the agency’s self-imposed cutoff for acting on a drug application. Results from the Scorpio-Pep trial were published May 14 in the New England Journal of Medicine.
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