Pharmaceutical firm Shionogi & Co. plans to seek state approval for its oral coronavirus drug by the end of this year in the hope of offering at-home treatment and easing strain on hospitals, company sources said Friday.
The Osaka-based firm expects the antiviral drug, which has been undergoing clinical trials since July, will prevent mild and moderate COVID-19 symptoms from worsening.
If approved, it would be the first oral drug in Japan for COVID-19 patients with mild cases. Currently, only an intravenous drug, which needs to be administered at hospitals, is available for patients with light symptoms in the country.
Due to a rapid surge in coronavirus infections in Japan, concerns have been mounting over a shortage of hospital beds and the rising number of patients recuperating at home, who could see their symptoms worsen while not getting proper medical attention.
Shionogi is also considering supplying the oral drug overseas and is discussing the matter with the Biomedical Advanced Research and Development Authority of the United States, sources said.
The company plans to apply for fast-track approval by the Ministry of Health, which would then not require it to complete clinical trials before putting the drug on the market, provided that it conducts the necessary study afterward.
While moving ahead with the trials, the company hopes to manufacture enough of the drug to treat up to 2 million patients in Japan by the end of this year, the sources said.