Overview
- The FDA cleared ensitrelvir, sold as Xocova, for use in people 12 years and older as the first U.S. oral option to prevent COVID-19 after a known exposure with a five-day pill regimen.
- Approval rested on the phase 3 SCORPIO-PEP trial, in which Xocova lowered the risk of symptomatic COVID-19 by 67% through day 10 compared with placebo in participants who were uninfected at baseline.
- The trial randomized roughly 1,030 people to ensitrelvir and 1,011 to placebo with a mean age of about 42 years and most participants starting prophylaxis within 48 to 72 hours of the index case’s symptom onset.
- Safety signals were similar between groups with overall adverse-event rates near 15% and the most common events reported as headache, diarrhea and cough, although labeling will note drug interaction and reproductive cautions.
- Experts say the drug could be useful for household contacts and high-risk congregate settings, but public health officials and clinicians will need real-world data and clear guidance on who should get the therapy and how to deliver it quickly after exposure.