Japanese pharmaceutical firm Shionogi & Co. said Friday it has applied for approval of its oral COVID-19 drug, after mid-phase clinical trials showed efficacy in reducing the coronavirus in the body.
It is the first such pill developed by a Japanese drugmaker and will be administered to mild-to-moderate coronavirus patients, regardless of whether they are at risk of hospitalization, to prevent the virus from multiplying in the body.
The Osaka-based firm said it had filed with the Health, Labor and Welfare Ministry for conditional early approval of the drug known as S-217622, following the results of phase-2 clinical trials.
The conditional early approval system allows drugmakers to skip the final stage of clinical trials once a certain level of efficacy and safety has been confirmed, according to the health ministry.
The system applies in cases where effective treatments for a disease are scarce and clinical trials may be protracted due to few test subjects.
Trials were conducted with a focus on people who became infected since the spread of the Omicron variant, Shionogi said in a press release.
During the process, patients took one dose of the drug daily over a period of five days and were found to show rapid reductions in viral load and improvement in symptoms compared with those who were given a placebo.
Shionogi has said it can start supplying between 400,000 and 500,000 doses of the drug in Japan by the end of February and 1 million doses by the end of March.
The firm is known for its infectious diseases treatments, such as influenza drug Xofluza and Tivicay for HIV.
In May 2020, the health ministry approved remdesivir, an anti-viral intravenous drug developed by U.S. firm Gilead Sciences Inc., three days after the company applied for emergency authorization of the treatment.
The oral COVID-19 drug Molnupiravir was granted special approval in December 2021, around 20 days after U.S. pharmaceutical firm Merck & Co. filed its application.