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Japan Firm To Seek Approval Of Oral COVID-19 Drug Before 2022
- By The Financial District
- Aug 8, 2021
- 2 min read
A Japanese pharmaceutical firm aims to apply within the year for conditional early government approval for oral medication that is being developed for patients with mild or moderate COVID-19 symptoms, its CEO told the Mainichi Shimbun in an Aug. 5 interview with Ai Yokota.
Photo Insert: If an oral medication preventing development of severe COVID-19 which people at the mild-symptom stage can take at home is put to practical use, then the response to the coronavirus may also change hugely.
Shionogi & Co. President and CEO Isao Teshirogi said the company is eyeing practical tests of the product, and that it is preparing a framework to distribute enough medication for 1 to 2 million people in Japan by the end of 2021.
They are reportedly also looking at supplying it abroad, with cooperation with the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) already underway.
At present, the only approved medications for people with mild COVID-19 symptoms are administered intravenously. If an oral medication preventing the development of severe COVID-19 which people at the mild-symptom stage can take at home is put to practical use, then the response to the coronavirus may also change hugely.
Pharmaceutical firms in the U.S. and Europe including Pfizer Inc. are also expediting development with a view to practical application within the year.
Shionogi began Japan-based initial clinical trials in July. It envisages a course of treatment in the early stages of infection, with one dose daily over five consecutive days.
It is intended to reduce virus amounts in the body and suppress severe symptoms.
According to Teshirogi, depending on the state of progress going forward, the company expects to complete initial clinical trials by the end of September, and then intends to move toward a second phase of clinical trials on hundreds of people with mild symptoms of COVID-19.
