Tokyo/UNI: The Japanese Health Ministry has authorised the island nation's first locally made COVID-19 oral treatment, Xocova, for emergency use.
This emergency approval was granted on the anticipated efficacy of Xocova and the acceptability of its safety profile based on the results obtained through the Phase 2 part (497 cases including the Phase 2a and Phase 2b parts combined) and the Phase 3 part (1,821 cases) of the Phase 2/3 study.
The pill was developed by Osaka-based pharmaceutical firm Shionogi & Co to treat coronavirus patients after they develop initial symptoms, such as fever, cough, a sore throat, a runny nose, and fatigue.
Xocova is an oral antiviral agent administered once daily for five days that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.
It has been proven the most effective when administered during the first three days of symptoms starting.
The drug is known to reduce the viral load to three percent when taken on day four, and is not recommended for use during pregnancy.
Shionogi had filed for manufacturing and sales approval on Feb. 25, 2020.
The company said it had enough pills to treat one million people, and the drug will hit the shelves in Dec.