Kazuaki Hashiguchi

Eiji Ueda

Fumiyoshi Sakai

Hidemaru Yamaguchi

Naomi Kumagai

Motoya Kohtani

Seiji Wakao

Kasumi Haruta

Luca Sogi

Muraoka

Shinichiro Muraoka

Shinya Tsuzuki

Stephen Barker

- The FDA has **accepted** Shionogi's New Drug Application (NDA) for **ensitrelvir** (S-217622), an investigational oral antiviral for the **prevention of COVID-19 following exposure** to an infected individual, which, if approved, would be the **first and only oral therapy** for this indication.  **[1281721_996ef895686e4f7b9df3ec0088312e5c_0]** 
- The NDA is supported by results from the global Phase 3 Study, **SCORPIO-PEP**, and the FDA has set a Prescription Drug User Fee Act (PDUFA) action date of **June 16, 2026**.  **[1281721_996ef895686e4f7b9df3ec0088312e5c_0]** 
- Ensitrelvir, known as Xocova® in countries where it is approved, received **emergency regulatory approval in Japan in November 2022 and full approval in March 2024 for the treatment of COVID-19**.  **[1281721_996ef895686e4f7b9df3ec0088312e5c_1]**

Shionogi's Ensitrelvir NDA Accepted by FDA for COVID-19 Prevention

SHIONOGI & CO (SGIOY)