The U.S. Food and Drug Administration has approved Shionogi’s Xocova (ensitrelvir), an oral antiviral, for postexposure prophylaxis (PEP) of COVID?19 in adults and adolescents aged 12 years and older.
Xocova is approved as a five-day, oral regimen with three tablets taken on day 1 (375 mg) and one tablet taken on days 2 through 5 (125 mg).
The approval is based on results from the Phase III SCORPIO-PEP trial, which included 2,387 study participants with a negative local screening test for severe acute respiratory syndrome coronavirus 2 infection and no symptoms at the time of enrollment, but who had been exposed to a person living in their household with symptomatic COVID-19.
Those randomly assigned to Xocova had a significantly lower risk for symptomatic COVID-19 (67% lower), the primary outcome, through day 10, compared with placebo.
The trial also showed that Xocova was generally well tolerated, with similar rates of adverse events observed across groups (15.1 versus 15.5% [placebo]). The most common adverse events included headache, diarrhea, and cough, which occurred in ?1% in the Xocova group and at a greater frequency than in the placebo group.
“The FDA approval of Xocova provides an important new approach to preventing COVID-19, which continues to impact lives,” Frederick Hayden, M.D., from the University of Virginia School of Medicine, said in a statement.
“The PEP strategy has the potential to benefit anyone who does not want to get COVID-19. It could be useful not only in household settings but also in other exposure circumstances, such as outbreaks in nursing homes, chronic or acute care facilities, and following travel-related exposures.”
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