TOKYO, Mar 23 (Pulse News Wire) – Shionogi & CO.,LTD. (4507.T) secured approval for its antiviral drug Zocova (ensitrelvir fumarate) as a post-exposure prevention for COVID-19 in Japan based on positive results from the global phase three post-exposure prophylaxis trial (SCORPIO-PEP).
Zocova is now the world's first and only oral antiviral medication approved for preventing COVID-19 after exposure. The approval comes amid ongoing challenges posed by the pandemic, particularly concerning low vaccination rates and waning immunity over time. Zocova offers a crucial preventive measure, especially for those at higher risk of severe illness due to underlying health conditions or lack of vaccination. Zocova is indicated for patients aged 12 and older and is administered orally once daily for five days. Each tablet costs ¥7,090. The drug was initially granted emergency authorization in Japan in November 2022 and received regular approval in March 2024.
Shionogi continues to advance research and development efforts aimed at addressing emerging variants and future outbreaks. The company plans to swiftly provide necessary treatments, vaccines, and preventive medications as needed. The impact of this approval on Shionogi’s fiscal year ending March 2026 is expected to be minor. In addition to Japan, Shionogi has submitted applications for similar approvals in the United States, Europe, Singapore, and Taiwan. In the US, the FDA review target date is set for June 16, 2026. The company also signed licensing agreements with Medicines Patent Pool to broaden access to ensitrelvir fumarate in low- and middle-income countries.
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