COVID-19: Shionogi, application for approval of corona drug: S-217622
Shionogi:
February 25,
We applied to the Ministry of Health, Labor and Welfare to manufacture and sell a new coronavirus drug.
Apply for manufacturing and marketing approval:
Practical use based on clinical trial / intermediate analysis data.
Apply the “conditional early approval system”.
If approved, it will be the first domestic company to take medicine for mild and moderately ill patients.
S-217622 (development number):
The drug candidate “S-217622 (development number)” interferes with the action of enzymes required for virus growth.
Take once daily for 5 consecutive days in the early stages of infection.
Final stage clinical trial:
The final stage clinical trial that has been underway since September 2021.
Participants are gathered with the goal of about 2000 people.
Shionogi analyzed the results for about 400 of them.
After 3 doses:
Reduced amount of virus:
It was confirmed that the amount of virus capable of infecting was significantly reduced.
Respiratory symptoms score:
The score for respiratory symptoms such as sore throat and cough was said to have improved.
No major safety concerns were noted.
Also effective for Omicron type:
The drug was also effective for the mutant “Omicron” in laboratory-level analysis.
Future supply system:
Shionogi has been manufacturing since December 2009 in parallel with the development.
It will produce 1 million people by the end of March.
Since April, we have established a supply system for 10 million people a year.
Nihon Keizai Shimbun
https://www.nikkei.com/article/DGXZQOUF251JX0V20C22A2000000/
Shionogi applies for approval of oral COVID-19 medication
On Friday, Shionogi said the drug was found to be highly effective in a mid-stage clinical trial,
which was carried out mainly when cases of the Omicron variant were growing.
The firm says
the study covered 428 coronavirus patients aged 12 or older with mild to moderate symptoms within five days after they tested positive.A five-day course of one daily dose was compared with a placebo.
Shionogi says that after the third dose,
less than 10 percent of the subjects given the drug had an infectious viral load — lower than in the placebo group.
It adds that significant improvements
were seen in respiratory symptoms, such as a stuffy or runny nose, sore throat, coughing and shortness of breath.
It says no serious side effects were observed.
Shionogi says final-stage trials involving around 2,000 people are ongoing.
But it says it filed for “conditional early approval” of the medication in Japan
ahead of other countries following the results of the mid-stage trial.
Two other oral medications for mild COVID-19 have been authorized in Japan.
Both were developed by foreign pharmaceutical firms.
Shionogi says that by the end of March,
it plans to manufacture enough for one million people, and from April, enough for more than 10 million people annually.
NHK WORLD-JAPAN News