Shionogi’s new COVID-19 prevention drug has received European Commission (EC) approval, making it the first oral anti-viral post-exposure prophylaxis for the virus authorised in the EU.
The approval for the drug, Zokovea (ensitrelvir), covers adults and adolescents aged 12 years and older and will provide eligible household contacts an oral treatment option aimed at preventing symptomatic infection after exposure to COVID-19.
Zokovea, a SARS-CoV-2 main protease inhibitor, works by blocking a viral enzyme needed for SARS-CoV-2 to replicate.
This latest approval extends the role of oral antivirals beyond treating an established infection to use soon after a known exposure to reduce.
Ensitrelvir is also authorised for post-exposure prophylaxis in Japan and the US, where it is marketed as Xocova.
Matteo Bassetti, Full Professor of Infectious Diseases of the University of Genoa, said: “This approval marks a significant shift in the role of oral antivirals for COVID-19: moving from treating patients with confirmed infection to the possibility of early intervention following known exposure to an infected contact, with the aim of preventing symptomatic disease.
He added: “Alongside vaccination, this introduces an additional prevention strategy, expanding the range of tools available to help protect at-risk individuals.”
The decision is based on the phase 3, multicentre, randomised, double-blind SCORPIO-PEP trial, which enrolled 2,387 people who had been exposed to a household member with symptomatic COVID-19.
In the primary analysis population, treatment with Zokovea was initiated within 72 hours of when the household member with COVID-19 began showing symptoms and significantly reduced the risk of developing symptomatic COVID-19 through Day 10 by 67% compared with placebo.
According to Shionogi, it is the first phase 3 study of an oral antiviral to demonstrate efficacy for the post-exposure prophylaxis of COVID-19.
Adverse events were reported in 15.1% of the Zokovea group and 15.5% of the placebo group, with headache, diarrhoea and cough among the most common events reported more frequently with Zokovea.
Huw Tippett, CEO, Shionogi Europe, said: “The European Commission approval of Zokovea represents an important regulatory milestone for Shionogi and reflects the strength of the clinical evidence supporting Zokovea for post-exposure prophylaxis of COVID-19.
“Shionogi remains committed to advancing innovative medicines for infectious diseases and supporting public health preparedness through scientific innovation,” he added.
Following EC approval, a regulatory submission to the MHRA will now follow.
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