Shionogi & Co., Ltd. announced that it has obtained standard approval from the Ministry of Health, Labour and Welfare (MHLW) for Xocova®? (Generic name: ensitrelvir fumaric acid), a novel anti-SARS-CoV-2 drug for the indication of SARS-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 3 portion of Phase 2/3 study (SCORPIO-SR) conducted in Japan, South Korea and Vietnam.

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, it has 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.