Taiwan Accepts New Drug Application for COVID-19 Treatment Ensitrelvir
Shionogi & Co., Ltd. has announced a significant milestone in the fight against COVID-19 with the Taiwan Food and Drug Administration accepting a new drug application (NDA) for ensitrelvir fumaric acid, an investigational oral antiviral. This development is part of Shionogi's ongoing efforts to combat the global pandemic by providing effective and safe treatment options.
About Ensitrelvir
Ensitrelvir is a 3CL protease inhibitor that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease, an enzyme essential for the virus's replication. Developed through joint research between Hokkaido University and Shionogi, ensitrelvir has already received emergency regulatory approval in Japan in 2022 and full approval in March 2024, where it is known as Xocova®. It was also made available in Singapore in November 2023 based on the Special Access Route application.
Clinical Development and Global Impact
Shionogi's commitment to addressing the global health challenge posed by COVID-19 is evident in its robust clinical development program for ensitrelvir. The company has conducted several studies, including SCORPIO-HR, SCORPIO-PEP, and SCORPIO-SR, a Phase 2/3 study in Asia during the Omicron-dominant phase of the epidemic. Data from these studies have been published in JAMA Network Open, highlighting the safety and efficacy of ensitrelvir.
Furthermore, Shionogi is involved in an investigator-initiated research study for hospitalized COVID-19 patients as part of the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership. The company is also studying the safety and efficacy of ensitrelvir in children aged 6 to 11 years in Japan.
Forward-Looking Statements
Shionogi's announcement includes forward-looking statements based on current expectations and assumptions subject to risks and uncertainties. These include general economic conditions, regulatory approvals, product safety and efficacy concerns, and manufacturing and marketing risks. Shionogi disclaims any obligation to update these statements based on new information or future events.
This acceptance of the NDA by the Taiwan Food and Drug Administration represents a hopeful step forward in the global effort to manage and treat COVID-19, offering a new treatment option for patients in Taiwan and potentially beyond.
