MHLW (Japan) grants full approval for Xocova ( ensitrelvir) to treatSARS-CoV-2 infection in Japan

Shionogi obtained emergency regulatory approval for Xocova in November 2022 and submitted an application for standard approval in May 2023. Xocova is the first COVID-19 treatment antiviral to receive standard approval in Japan.

The standard approval of Xocova is based on positive results from the Phase III portion of Phase II/III study (SCORPIO-SR) conducted in Japan, South Korea and Vietnam1. The study was conducted in a predominantly vaccinated population, regardless of risk factors for severe disease. Xocova is the first antiviral agent to show both clinical symptomatic efficacy for five typical COVID-19 symptoms (primary endpoint) and antiviral efficacy in patients with mild-to-moderate SARS-CoV-2 infection.

Furthermore, we have included additional results regarding the efficacy, such as viral titers, as well as safety information from over 900,000 patients (estimated) obtained in post-emergency approval use in support of the standard approval application.

As a result, the regulatory authorities determined that the efficacy and safety of Xocova has been sufficiently confirmed to grant standard approval. With this standard approval, it is no longer necessary to obtain written consent from the patient before the prescription of Xocova and it is expected that Xocova can be used with greater confidence and contribute even further to the treatment of a broad range of COVID-19 patients, regardless of risk factors for severe disease.