TOKYO, Jun 01 (Pulse News Wire) – Shionogi & CO.,LTD. (4507.T) announced that its subsidiary, Shionogi Inc., received approval from the US Food and Drug Administration (FDA) for ensitrelvir fumarate as a post-exposure preventive treatment for COVID-19.
The approval is based on positive results from the global Phase 3 SCORPIO-PEP trial, which showed a statistically significant reduction in the risk of developing COVID-19 within 10 days compared to placebo. Ensuring good tolerability, ensitrelvir is now the first oral antiviral drug approved in the US for preventing COVID-19 symptoms after exposure. This approval follows extensive clinical trials, including domestic studies conducted since 2022.
In Japan, ensitrelvir was granted emergency authorization in November 2022 and regular approval in March 2024. Additional applications for expanded age ranges and indications continue to progress globally, with ongoing reviews by regulatory bodies such as the European Medicines Agency (EMA). The company's efforts align with addressing public health challenges posed by emerging variants and low vaccination rates.
Shionogi remains committed to advancing research and development to swiftly address future outbreaks and provide necessary treatments and vaccines.
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