Shionogi：XOCOVA® (ensitrelvir)was approved for marketing in the United States.
On June 1, Shionogi announced that its oral antiviral drug XOCOVA® (ensitrelvir) has received U.S. FDA approval for post-exposure prophylaxis (PEP) of COVID-19 in adolescents aged 12 years and older and in adult patients.
This approval came more than two weeks ahead of the scheduled Prescription Drug User Fee Act (PDUFA) target date of June 16. This milestone marks the official arrival of the first and only oral antiviral approved for COVID-19 post-exposure prophylaxis in the U.S. healthcare market, providing a critical preventive tool for clinical use.
Core Clinical Data: 67% Prevention Rate
The approval of XOCOVA is based on positive results from the pivotal Phase III clinical study SCORPIO-PEP. This study is the only Phase III trial of an oral antiviral to date that has achieved the primary endpoint of “preventing the development of symptomatic COVID-19 infection following exposure.”
Risk Reduction of Symptomatic Infection:
Among uninfected individuals exposed to a confirmed COVID-19 case, the XOCOVA group demonstrated a significant 67% reduction in the risk of developing symptomatic COVID-19 infection by Day 10 compared with the placebo group (study participants: XOCOVA group n=1,030; placebo group n=1,011).
Dosing Regimen:
The drug is administered as a five-day oral regimen: 3 tablets on Day 1, followed by 1 tablet daily from Day 2 through Day 5.
Safety Profile:
In clinical trials, XOCOVA demonstrated a favorable tolerability profile. The incidence of adverse events was similar between the two groups: 15.1% in the XOCOVA group versus 15.5% in the placebo group. Common adverse events (incidence ≥1% and higher than placebo) included headache, diarrhea, and cough. Notably, no drug-related dysgeusia (taste disturbance) was reported in the trial.
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