Japan’s Shionogi Announces Setback in Covid-19 Treatment Trial

Japan’s Shionogi Announces Setback in Covid-19 Treatment Trial

Japan-based pharmaceutical company Shionogi & Co. revealed that its pill-based treatment for Covid-19, known as Xocova, did not achieve the desired outcome in a global late-stage trial. Despite this setback, the drug exhibited strong antiviral properties when compared to a placebo. Shionogi had projected annual sales worth $2 billion in the US, contingent upon regulatory approval. Xocova is expected to compete with Pfizer’s antiviral drug, Paxlovid. The CEO of Shionogi had previously expressed optimism about securing US approval by early 2025. Xocova obtained emergency approval in Japan in November 2022 and received full approval in March 2024. Notably, Xocova was the first domestically produced oral treatment for Covid-19 in Japan. The Japanese government had procured 2 million courses of the drug, but most of it remains unused and is now slated for destruction. The US FDA had granted Xocova Fast Track designation in 2023. The clinical trial in question, SCORPIO-HR, formed part of the US National Institutes of Health’s public-private partnership for Covid-19 treatments and vaccines. Shionogi has stated that it will continue collaborating with regulatory authorities to make ensitrelvir available, although no further specifics have been provided.

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TIS Staff

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