COVID-19: Fujifilm to re-execute AVIGAN clinical trials: in April in Japan
FUJIFILM Holdings:
In April, it decided to re-execute clinical trials (clinical trials) in Japan for the drug candidate “AVIGAN” for the new coronavirus infection.
The corona therapeutic drug approved in Japan is “therapeutic drug developed overseas such as remdesivir”, and there are only two cases.
Japanese goverment:
In December 2020, AVIGAN approval was once postponed because it was difficult to judge its effectiveness.
AVIGAN is expected to be re-examined after the October Med trial.
Already, AVIGAN is virtually prescribed by 1,000 medical institutions in Japan in a framework called observational studies.
Nihon Keizai Shimbun
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.