Shionogi seeks approval for pediatric COVID-19 treatment

Shionogi & Co., Ltd. (TSE:4507) announced the submission of a supplemental New Drug Application (sNDA) to Japan's regulatory authorities seeking approval to expand the indication of ensitrelvir, known as Xocova®, for the treatment of COVID-19 in pediatric patients aged 6 years and older, weighing at least 20 kg. The application also includes a new 25mg tablet formulation to facilitate easier administration for pediatric patients. The sNDA is based on positive Phase 3 study results (jRCT: 2031230140) demonstrating safety, tolerability, and similar pharmacokinetics to adult patients, as well as a potent antiviral effect. Shionogi hopes ensitrelvir will become a new treatment option for this age group, which currently lacks approved oral antiviral options. Ensitrelvir has been granted Fast Track Designation by the FDA for both treatment and post-exposure prophylaxis of COVID-19. A sNDA for ensitrelvir for post-exposure prophylaxis of COVID-19 in Japan based on Phase 3 SCORPIO-PEP trial was submitted in 2025. The drug is under regulatory review in Taiwan and is available in Singapore via a Special Access Route application.