COVID-19：Fujifilm重新执行AVIGAN临床试验：4月在日本
FUJIFILM Holdings：
今年4月，它决定在日本针对新的冠状病毒感染的候选药物“ AVIGAN”重新执行临床试验（临床试验）。
在日本批准的电晕治疗药是“ remdesivir等国外开发的治疗药”，只有两个案例。
日本政府：
2020年12月，AVIGAN的批准一度被推迟，因为难以判断其有效性。
AVIGAN有望在10月Med试验后重新检查。
AVIGAN实际上已经由日本的1,000家医疗机构在称为观察研究的框架中开出处方。
日本经济新闻
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.