Drugmaker Shionogi applies for oral COVID pill approval in Japan
It is the first such pill developed by a Japanese drugmaker.
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 2a» clinical trials.
The drug has been developed for mild-to-moderate coronavirus cases, regardless of whether patients are at risk of hospitalization. It is believed to prevent the virus from multiplying in the body.
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.