Tokyo: The Japanese health ministry on Tuesday authorized the country’s first domestically produced oral medicine against Covid-19, Xocova, for emergency use.
The pill was developed by Osaka-based pharma firm Shionogi & Co to treat coronavirus patients after they develop initial symptoms, such as fever, cough, a sore throat, a runny nose, and fatigue, reports Sputnik news agency.
Xocova has been proven the most effective when administered during the first three days of symptoms starting. It helps reduce the viral load to 3% when taken on Day 4. The drug is not recommended for use during pregnancy, it said.
“Unlike oral drugs that have been approved so far, Xocova can be used among people with mild to moderate symptoms without risk factors,” said Japan’s Health Minister Katsunobu Kato.
Country’s Pharmaceuticals and Medical Devices Agency, which conducted the preliminary review, acknowledged in a report that it had “obtained sufficient information to presume the drug is effective” from final phase clinical trial results submitted by Shionogi.
A health ministry panel in July had postponed granting an emergency approval for the drug after the Japanese pharmaceutical firm was unable to demonstrate its efficacy in its mid-phase clinical trials, as reported by Kyodo news agency.
Japan had already authorized the use of two oral COVID-19 drugs developed by U.S. pharmaceutical firms Pfizer Inc. and Merck & Co., respectively, for patients with mild symptoms.
Shionogi submitted the registration application in February 2020. The drug will hit the shelves in December.