COVID-19：FDA､ファビピラビルの治験承認：Appili 社（動画）：
Favipiravir Oral Tablet Approved by FDA for Clinical Trials in the US：
FDA批准的Favipiravir口服片剂在美国进行临床试验
COVID-19：
抗ウイルス薬ファビピラビル：
SARS-CoV-2に対し、ファビピラビルの有効性が世界で広まっています。
- ロシア、
- 中国、
- インド、
軽度のCOVID-19患者向けに、既に治療薬として承認されています。
米国でファビピラビル治験：
ついに、ファビピラビルの治験が、アメリカで開始します。
Appili Therapeutics Inc.：
抗感染薬ファビピラビルに焦点を当て、治験実施を発表しました。
FDA、米国での治験認可：
Appili社が、ファビピラビルの新薬申請（IND）を提出。
FDAは、その後、同社の治験実施について許可しました。
フェーズ2の臨床試験：
Appiliは、フェーズ2の臨床試験を米国全土に拡大します。
現在、長期ケア施設において、COVID-19集団発生・拡大防止のため、ファビピラビルの安全性・有効性を評価中。
第2相臨床試験では、長期ケア環境での経口錠剤として、ファビピラビルの多様性を活用します。
米国とカナダで実施：
米国とカナダの両方で、この第2相臨床試験に最大760人の参加者を登録する予定です。
カナダ保健省：
既に5月21日、COVID-19予防策として、富士フイルム（FFTC）ファビピラビルを評価する第2相試験の規制クリアランスを発表済み。
Favipiravir
Favipiravir was originally developed and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza outbreak under the name AVIGAN.
Following promising clinical studies, Russia and India recently approved favipiravir-based antiviral medications for the emergency treatment of COVID-19.
Researchers
are conducting additional trials evaluating favipiravir as a treatment for COVID-19 in countries, including
- the United States,
- Japan,
- China, and
- the United Kingdom.
TrialSite has followed the pathway of the research around the world.
Of note, favipiravir was an antiviral
that caught the interest of the U.S. Department of Defense (DOD). Just five years ago, the DOD spent over $200 million on favipiravir clincial trials involving a company called MediVector.
Appili Therapeutics current Chief Executive Officer, Dr. Armand Balboni, was involved with those DOD-based initiatives so he knows a great deal about the drug and its potential.
The Elderly Must be Protected
In a press release today, Dr. Allison McGeer, a senior clinical scientist at the Lunenfield-Tanenbaum Research Institute at Sinai Health, and principal investigator of the trial, reports,
“The elderly are at the highest risk for contracting the disease and the rising rates of COVID-19 infection currently seen in much of the U.S. will likely continue to be a major threat to those living and working in long-term care facilities.”
Dr. McGeer suggests that a randomized controlled trial will help medical professionals better understand if the Japanese antiviral represents a potential option to control outbreaks.
Dr. Armand Balboni, Chief Executive Officer at Appili Therapeutics, commented,
The burden of illness in long-term care centers continues to be a significant problem,
and finding ways to offer LTC residents and staff protection against COVID-19 with an oral treatment would be a significant advantage in our fight to control the devastating effects of this pandemic.
Dr. Balboni continued,
The limited response to vaccines often seen in the elderly further supports expanding this trial into the U.S. Favipiravir is an antiviral that can be administered orally as a tablet, without the need to be given intravenously or as injections, and may be an important option to avoid and/or control outbreaks in elderly residents living in LTC facilities.
Of course, the company had to disclose in its press release that it isn’t making any express or implied claims that it has the ability to eliminate, cure or contain the COVID-19 virus.
FDA Clears Favipiravir for COVID-19 Facility Outbreak Prevention Study
https://www.contagionlive.com/news/fda-clears-favipiravir-covid19-facility-outbreak-prevention-study