COVID-19: FUJIFILM confirms effectiveness in Avigan clinical trial “: To apply for approval next month
FUJIFILM:
FUJIFILM has announced that it has confirmed certain efficacy in a clinical trial of administering Avigan to patients with COVID-19.
Next month, we will apply for approval as a therapeutic drug for the new coronavirus.
Results of clinical trial:
According to Fujifilm, a clinical trial to administer to patients and aim for national approval.
It was conducted on 156 patients aged 20 to 74 years.
Time to become negative:
As a result of examining the period until the symptom improved and the PCR test became negative,
14.7 days in the group not receiving Avigan
11.9 days in the treated group
It was about 3 days short.
Safety concerns:
In addition, there were no other side effects such as decreased renal function or liver function.
There were no safety concerns.
“Abigan” clinical trial:
Initially it was scheduled for the end of June.
However, due to the decrease in the number of infected people, the schedule was extended and the trial was continued.
NHK news
https://www3.nhk.or.jp/news/html/20200923/k10012630761000.html
Japanese Health Ministry Could Approve Favipiravir (Avigan) Before End of Year Targeting COVID-19
Japanese Health Ministry Acknowledges Potential Fast-Track
The drug was initially developed as a flu treatment by developer Fujifilm Toyama Chemical.
The sponsor initiated clinical trials back in March, which concluded recently.
Nikkei Asian Review reports that the study results are still under review,
but the prominent news platform reports that “…[T]he drug apparently has shown some effectiveness against coronavirus.”Apparently, the Japanese health ministry will fast-track approval should the data review turn out positive.
Recently, a ministry source quoted, “If the data from the clinical trials looks good, we could approve it in a month from when Fujifilm submits an application.”
The government, via the previous Prime Minister Shinzo Abe,
sought a fast-track previously but there was a lack of patient subjects.North American Activity
Sponsors of one kind or another are conducting at least 34 favipiravir-based clinical trials targeting COVID-19. In Canada,
Appili Therapeutics
is working on developing and commercializing the product for the North American market.Meanwhile, prestigious universities, such as Stanford, conduct favipiravir studies in the United States.
Fujifilm Toyama Chemical itself
is conducting a U.S.-based clinical trial (NCT04358549) scheduled for completion November 1, 2020.
Fujifilm Unit to Apply for Avigan Use for Coronavirus – JIJI PRESS
https://jen.jiji.com/jc/i?g=eco&k=2020092300630