Fujifilm is moving quickly into phase III clinical trials of Avigan Tablets for COVID-19 and they are committed to increasing production. We have been covering this “wonder drug” for a while now ( 1, 2, 3, 4, 5, 6) and every day there seems to be more positive news about Avigan now. For those unaware here are the IV levels of trial and what the cover:
Phase 0 clinical trials: Exploring if and how a new drug may workPhase I clinical trials: Is the treatment safe?Phase II clinical trials: Does the treatment work?- Phase III clinical trials: Is it better than what’s already available?
- Submission for FDA approval: New drug application (NDA)
- Phase IV clinical trials: What else do we need to know?
Once Fujifilm passes Phase III they can submit Avigan Tablets to the FDA for use in the United States for the treatment of COVID-19, which is probably similar in other countries. You can read the full press release below
Press Release:
Fujifilm announces the start of a phase III clinical trial of influenza antiviral drug “Avigan Tablet” on COVID-19 and commits to increasing production
TOKYO, March 31, 2020 — FUJIFILM Toyama Chemical Co., Ltd. (President: Junji Okada) has announced today the initiation of a phase III clinical trial to evaluate the safety and efficacy of influenza antiviral drug “Avigan Tablet” (generic name: favipiravir) in Japan for patients of COVID-19, a respiratory infection caused by the novel Coronavirus (SARS-CoV-2).
Following the rapid and global outbreak of COVID-19, on March 11 2020 the World Health Organization (WHO) announced the Coronavirus had become a global pandemic. As the number of COVID-19 patients continues to increase around the world, the development of effective treatments is urgently required.
Avigan, approved for manufacture and sale as an influenza antiviral drug in Japan, has a mechanism of action for selectively inhibiting RNA polymerase involved in influenza viral replication. Due to this mechanism, it is expected that Avigan may potentially have an antiviral effect on the new coronavirus as it is classified into the same type of single-stranded RNA virus as influenza, and its clinical application to treat COVID-19 is now under study.
In early March, Fujifilm already began increased production of Avigan and now plan to accelerate the production of Avigan through cooperation with domestic and overseas partners for responding to the needs of the Japanese government and other countries.
Fujifilm intends to sincerely cooperate with the supply of Avigan to such countries in consultation and coordination with the Japanese government to combat COVID-19 and contribute to tackling the spread of this global pandemic at the earliest possible stage.
[About “Avigan®Tablet”]
Avigan Tablet was approved for manufacture and sale in Japan in 2014 as an influenza antiviral drug. The drug is to be considered for use only when there is an outbreak of novel or re-emerging influenza virus infections in which other influenza antiviral drugs are either not effective or insufficiently effective, and the Japanese government decides to use the drug as a countermeasure against such influenza viruses. The drug is to be supplied only at the discretion of Japan’s Health, Labor and Welfare Ministry. It is therefore only manufactured and distributed upon request by the Japanese Government. As such, while the Japanese government has a certain stockpile of the drug, Avigan has never been distributed in the market and is not available at hospitals and pharmacies in Japan or overseas.
[About FUJIFILM Toyama Chemical Co., Ltd.]
FUJIFILM Toyama Chemical Co., Ltd. conducts the research, development, manufacture, and sales of radiopharmaceuticals and small molecule pharmaceutical products. Under close cooperation with FUJIFILM Corporation, it aims to develop innovative diagnostic and therapeutic radiopharmaceuticals, as well as therapeutic drugs having unique mechanisms of action in the fields of “oncology,” “central nervous system diseases,” and “infectious diseases” where significant unmet medical needs still exist. It also works to develop new medicines utilizing drug delivery system (DDS) technologies, designed to deliver the required amount of a drug in a timely manner to the specific body area. By exploring synergy with in vitro diagnostic devices and reagents owned by Fujifilm group companies, the company will expand its offering of comprehensive solutions from diagnosis to treatment. FUJIFILM Toyama Chemical have expanded its business areas to medical IoT solutions including a system to support pharmacists’ drug dispensing auditing work, and a transportation device that enables strict temperature control suited for blood products, cells and tissue used for regenerative medicine. Through the development and supply of high-quality, high added-value new drugs and products that support the clinical settings, FUJIFILM Toyama Chemical strives to solve various social challenges, and contribute to improving medicine and enhancing the quality of life. For more information, please visit http://fftc.fujifilm.co.jp/en/
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