Japan Fast-Tracking Avigan To Market
Japan’s health ministry decided to allow pharmaceutical companies to bypass standard clinical trial procedures to facilitate the fast-track approval of the anti-flu medicine Avigan as an early-stage treatment for COVID-19 disease.
According to media reporting on May 13, 2020, the exception will be applied for Avigan (favipiravir) applications that satisfy either of two requirements: public studies conducted on the drug meet global standards or companies that developed the drug plan to conduct clinical trials and submit the results ‘after’ the Avigan has become available.
Initially, Avigan (T-705) Tablet was initially was approved for sale in Japan in 2014 as an influenza antiviral medication.
Since then, Avigan has been found effective against a wide range of types of influenza viruses.
Additionally, Avigan has shown anti-viral activities against RNA viruses such as arenaviruses, bunyaviruses, and filoviruses, all of which are known to cause fatal hemorrhagic fever.
Avigan (favipiravir) undergoes an intracellular phosphoribosylation to be an active form, favipiravir-RTP (favipiravir ribofuranosyl-5′-triphosphate), which is recognized as a substrate by RdRp, and inhibits the RNA polymerase activity.
Since the catalytic domain of RdRp is conserved among various types of RNA viruses, this mechanism of action underpins a broader spectrum of anti-viral activities.
In the USA, leading hospital centers in Massachusetts are currently evaluating Avigan in Phase 2 clinical trial, with an expected completion date of August 2020.
These Boston area hospitals are currently recruiting COVID-19 patients for this study: Brigham and Women's Hospital, Massachusetts General Hospital, UMass Memorial Health Care.
During early May 2020, Japan shipped Avigan to 43 countries for testing it with mild and moderate patients. Japan’s Foreign Minister Toshimitsu Motegi said these distributions will be ‘free of charge.’
Avigan is supplied at the discretion of Japan’s Health, Labor, and Welfare Ministry. Avigan is not approved for commercial distribution in the USA or any country.
Previously, China announced on March 17, 2020, it will officially adopt Avigan as part of its treatment guidelines for the new coronavirus disease.
However, there are concerns Avigan may cause birth defects. Therefore, Japan says ‘it cannot be used on pregnant women.’
COVID-19 disease therapeutic development news published by CoronavirusToday.