COVID-19：富士フイルム､AVIGANの治験を再実施へ：日本で4月に（動画）：
COVID-19:Fujifilm to re-execute AVIGAN clinical trials:in April in Japan:
COVID-19：Fujifilm重新执行AVIGAN临床试验：4月在日本
富士フイルムホールディングス：
新型コロナウイルス感染症の治療薬候補「AVIGAN」について、4月に国内で臨床試験（治験）を再実施する方針を固めた。
日本国内で承認されたコロナ治療薬は、「レムデシビルなど､海外で開発された治療薬」で、2例しかない。
日本政府：
2020年12月に、有効性の判断が難しいとして、AVIGAN承認を一度見送った。
AVIGANの再審査は10月メドの治験終了後になる見込み。
既に、AVIGANは観察研究と呼ばれる枠組みで、日本の1千の医療機関で実質的に処方されている。
日本経済新聞
https://www.nikkei.com/article/DGXZQODZ02DN90S1A200C2000000/
Back to the Drawing Board for Fujifilm Holdings’ Favipiravir in Japan as it Must Now Execute Another Phase 3 Clinical Trial
Favipiravir in Japan
Approved in numerous countries, from Russia and Indonesia and India on an emergency basis, Japan’s health ministry simply delayed any decision.
While the drug’s targeted indication was patients with early onset, mild COVID-19,
the Japanese regulators are on record that it was too difficult for them to identify the drug’s efficacy from existing data.
This has led to a complete regrouping for the drug’s maker—Fujifilm Holdings—and its approach.
Fujifilm
will embark on a new clinical trials program in close collaboration upfront with the Ministry of Health, Labor and Welfare in a bid to improve scope and methods in a bid to bolster chances of better results.
The new placebo-controlled clinical trial, reports Nikkei,
will include patients who are 65+ of age with mild COVID-19 symptoms in addition to those 50 and up and mildly ill who may have existing health conditions, such as diabetes or kidney disorders.
This time, a double-blinded study involving up to 270 participants,
the bar is high for regulators in places such as Japan, the USA or Europe.
With an end date targeting the Fall, Fujifilm hopes to seek approval by October 2021.