https://www.japantimes.co.jp/news/2...lth-ministry-approve-remdesivir/#.Xq9aFaj7TIU
Japan health ministry expediting remdesivir for COVID-19 patients
The health ministry will apply a special approval system to shorten the screening time for the antiviral Ebola drug remdesivir, which has just been approved for emergency use in coronavirus patients in the U.S. | POOL / AFP-JIJI
JIJI, REUTERS, KYODO
ARTICLE HISTORY
The health ministry is moving to approve the antiviral drug remdesivir to treat domestic coronavirus patients.
The move on Satuday followed U.S. President Donald Trump's announcement the previous day that the Food and Drug Administration had authorized the emergency use of the drug for COVID-19 patients. Remdesivir was originally developed by Gilead Sciences Inc. as an Ebola remedy but failed.
If given the go-ahead, remdesivir would become Japan's first recognized remedy for the respiratory disease caused by the novel coronavirus.
To greenlight remdesivir, the health ministry will apply a special approval system that allows screening to be substantially shortened on condition that the drug in question has been approved overseas.
On Saturday afternoon, the government, at a round-robin-style Cabinet meeting, revised a related ordinance in such a way to make it possible to apply the special approval system to remdesivir.
RELATED STORIES
Japan's approval process usually takes about a year based on domestic clinical trials. Expectations are especially high that remdesivir will help severely ill patients.
In late April, the government said remdesivir needs to be introduced for emergency use and that fast-track procedures to greenlight domestic sales were being prepared under the pharmaceuticals and medical devices law.
After receiving the application from Gilead Sciences, the health ministry will collect opinions on safety and other aspects of the drug at a meeting of its Pharmaceutical Affairs and Food Sanitation Council.
Remdesivir, which previously failed as a Ebola treatment, is being tried against COVID-19 because it is designed to disable the mechanism by which certain viruses, including the coronavirus, copy themselves to overwhelm the host's immune system.
According to a recent study published by the New England Journal of Medicine, the drug was effective in nearly 70 percent of 53 coronavirus patients with severe symptoms, but caused serious side effects, including deterioration of kidney and liver functions, in a quarter of them.
The government, however, has not applied the special approval system to the flu drug Avigan, because its sales prospects overseas are unclear. Instead, the government is proceeding with clinical trials.
Avigan is widely viewed as a potential treatment for COVID-19. It was developed by Tokyo-based Fujifilm Toyama Chemical Co., an affiliate of Fujifilm Holdings Corp.
Japan health ministry expediting remdesivir for COVID-19 patients
The health ministry will apply a special approval system to shorten the screening time for the antiviral Ebola drug remdesivir, which has just been approved for emergency use in coronavirus patients in the U.S. | POOL / AFP-JIJI
JIJI, REUTERS, KYODO
ARTICLE HISTORY
The health ministry is moving to approve the antiviral drug remdesivir to treat domestic coronavirus patients.
The move on Satuday followed U.S. President Donald Trump's announcement the previous day that the Food and Drug Administration had authorized the emergency use of the drug for COVID-19 patients. Remdesivir was originally developed by Gilead Sciences Inc. as an Ebola remedy but failed.
If given the go-ahead, remdesivir would become Japan's first recognized remedy for the respiratory disease caused by the novel coronavirus.
To greenlight remdesivir, the health ministry will apply a special approval system that allows screening to be substantially shortened on condition that the drug in question has been approved overseas.
On Saturday afternoon, the government, at a round-robin-style Cabinet meeting, revised a related ordinance in such a way to make it possible to apply the special approval system to remdesivir.
RELATED STORIES
- Gilead experimental COVID-19 drug remdesivir fails in human trial
- Virus drugmaker caught between making a profit and treating the world
- U.S. emergency approval broadens use of Gilead's COVID-19 drug remdesivir
- Japan to ease curbs on social contact and let some facilities reopen
Japan's approval process usually takes about a year based on domestic clinical trials. Expectations are especially high that remdesivir will help severely ill patients.
In late April, the government said remdesivir needs to be introduced for emergency use and that fast-track procedures to greenlight domestic sales were being prepared under the pharmaceuticals and medical devices law.
After receiving the application from Gilead Sciences, the health ministry will collect opinions on safety and other aspects of the drug at a meeting of its Pharmaceutical Affairs and Food Sanitation Council.
Remdesivir, which previously failed as a Ebola treatment, is being tried against COVID-19 because it is designed to disable the mechanism by which certain viruses, including the coronavirus, copy themselves to overwhelm the host's immune system.
According to a recent study published by the New England Journal of Medicine, the drug was effective in nearly 70 percent of 53 coronavirus patients with severe symptoms, but caused serious side effects, including deterioration of kidney and liver functions, in a quarter of them.
The government, however, has not applied the special approval system to the flu drug Avigan, because its sales prospects overseas are unclear. Instead, the government is proceeding with clinical trials.
Avigan is widely viewed as a potential treatment for COVID-19. It was developed by Tokyo-based Fujifilm Toyama Chemical Co., an affiliate of Fujifilm Holdings Corp.
