FDA Approves Ensitrelvir to Prevent COVID-19 After Exposure

Phase 3 data showed a 67% reduction in symptomatic infection among exposed household contacts who tested negative at baseline.

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The FDA has approved ensitrelvir (XOCOVA) for postexposure prophylaxis of COVID-19 in individuals aged 12 and older.
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Ensitrelvir is the first oral option approved to prevent COVID-19 following exposure to an infected individual.
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The approval was based on the phase 3 SCORPIO-PEP trial, which enrolled 2,387 participants exposed to symptomatic COVID-19.
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Ensitrelvir reduced the risk of symptomatic COVID-19 by 67% compared to placebo among uninfected participants.
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The most common adverse events with ensitrelvir were headache, diarrhea, and cough, with overall rates similar to placebo.

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