Drugmaker Shionogi Seeks Approval Of COVID Pill In Japan

Japanese pharmaceutical firm Shionogi & Co. said late on 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, Kyodo News reported.

Photo Insert: The drug is known as S-217622

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.

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 the influenza drug Xofluza and Tivicay for HIV.

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