Shionogi Announces European Commission Approval of Zokovea® (ensitrelvir) for Post-Exposure Prophylaxis of COVID-19

Current Edition

Current Features

Subsection - Neurodegenerative Diseases

From Depression to Deep-Learning: Leveraging iPSC and AI Platforms for Evidence-Based Depression Treatment

Subsection - Oncology

Essential DMPK Strategies for IND Success

Subsection - Cell and Gene Therapy

When the Gene Editing Guide is the Drug

Shionogi Announces European Commission Approval of Zokovea® (ensitrelvir) for Post-Exposure Prophylaxis of COVID-19

Zokovea becomes the first oral antiviral medicine authorized in the European Union for the post-exposure prophylaxis of COVID-19*
Approval is based on the Phase 3 SCORPIO-PEP study evaluating Zokovea following household exposure to COVID-19[1]

Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) today announced that the European Commission (EC) has granted marketing authorisation for Zokovea® (ensitrelvir) for post-exposure prophylaxis (PEP) of COVID-19 in adults and adolescents aged 12 years and older.[2]

The approval of Zokovea as the first oral antiviral medicine authorised in the EU for post-exposure prophylaxis of COVID-19* adds a new option to the range of measures available to support COVID-19 preparedness. Together with vaccines, diagnostics and surveillance, antiviral medicines can form part of a broader range of complementary measures that support public health preparedness.[3]

Matteo Bassetti, Head of the Infectious Diseases Clinic of the Policlinico San Martino University Hospital in Genoa and 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. Alongside vaccination, this introduces an additional prevention strategy, expanding the range of tools available to help protect at-risk individuals.”

The EC’s decision is supported by results from the global Phase 3 SCORPIO-PEP, a multicenter, randomised, double-blind, placebo-controlled trial evaluating Zokovea in household contacts of individuals with COVID-19.1 In the primary analysis population, treatment with Zokovea was initiated within 72 hours of when the household member with COVID-19 began showing symptoms.1 Zokovea significantly reduced the risk of developing symptomatic COVID-19 through Day 10 by 67% compared with placebo (Zokovea n=1,030; placebo n=1,011).1 The study enrolled more than 2,300 adults and adolescents aged 12 years and older and represents the first Phase 3 study of an oral antiviral to demonstrate efficacy for the post-exposure prophylaxis of COVID-19.1

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.”

Outside the EU, ensitrelvir, marketed as Xocova® in Japan and the United States, is also approved in Japan for the treatment of COVID-19 and, in Japan and the United States, for post-exposure prophylaxis in adults and adolescents aged 12 years and older.[4],[5],[6]