Ministry To Continue Deliberation On Avigan
Japanese health ministry panel members say they are still not confident enough to approve the influenza drug Avigan to treat COVID-19 patients.
Members of the panel met behind closed doors on Monday to discuss the efficacy and safety of the drug developed by Fujifilm Toyama Chemical.
In October, the company applied for government approval for the drug to be used as a coronavirus treatment.
The ministry said the panel stopped short of approving it.
The panel concluded that, with only the data now at hand, it's difficult to determine if the drug is effective against the coronavirus.
The drug maker conducted what is known as "single-blind clinical trials," with patients receiving either Avigan or a placebo but not knowing which.
The drug maker said the trials showed that Avigan had helped to shorten the time required for patients to produce negative test results by 2.8 days.
But as doctors were allowed to know which was given to the patients, sources say panel members could not rule out the possibility of doctor bias on the data and asked not to make a decision at this time.
Health ministry officials say more time is needed to come to a decision and they will have panel members further review the data by referencing overseas trial cases.
As a result, a decision on whether to approve the drug for this new use will not be made by the end of this year.
Ministry officials say that this conclusion does not mean that the drug's efficacy has been denied.
