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Japan to consider early approval for Shionogi COVID-19 pill

Feb 08 (Japan Times) - Prime Minister Fumio Kishida said Monday that the government would consider granting conditional early approval for the oral COVID-19 treatment being developed by Shionogi & Co., with his remarks coming as the firm prepares to start a late-stage global trial.

Shionogi Chief Executive Isao Teshirogi told reporters that the company could file for early approval of the drug in Japan as soon as next week, and that it could deliver enough doses for 1 million people by the end of March.

Antiviral pills from Pfizer Inc and Merck & Co. are already being used in several countries and have demonstrated efficacy in trials of adults with COVID-19 who are at risk of serious illness.

Shionogi said that new results from an ongoing clinical trial of their pill, known as S-217622, showed a “significant difference” in anti-viral effect compared with a placebo, as well as symptom improvement.

Patients with no or mild COVID-19 symptoms were treated with its experimental drug and showed a viral load reduction of around 63% to 80% four days later compared with a placebo group, according to its small-scale study.

Source: ANNnewsCH

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