Avigan is an anti-influenza drug, approved for domestic use in March 2014, for the treatment of new or re-emerging influenza viruses
Midtown West, the current global headquarters of Fujifilm in Tokyo. (Credit: Mapio/Wikipedia.)
Fujifilm Toyama Chemical has commenced a new Phase 3 clinical trial of its anti-influenza drug Avigan (favipiravir) in Japan, targeting patients infected with Covid-19 infections.
The double-blind, placebo-controlled Phase 3 study is designed to determine the efficacy and safety of Avigan in patients with early-onset Covid-19, who are at risk of disease progression.
Avigan is an anti-influenza drug, approved for domestic manufacturing and marketing in March 2014, for the treatment of new or re-emerging influenza viruses.
The drug works by a mechanism of action for selectively inhibiting RNA polymerase involved in influenza viral replication and is believed to be effective against the novel coronavirus, said the company.
In March last year, Fujifilm Toyama Chemical has started a Phase 3 clinical trial of Avigan, in Japanese patients with Covid-19 who are not presenting severe pneumonia.
The earlier Phase 3 study has met the primary endpoint, and the company has filed an application for partial changes to the manufacturing and marketing approval for Avigan.
Fujifilm Toyama Chemical said that numerous elderly Covid-19 patients saw their disease become severe and, their condition of patients with risk factors has rapidly deteriorated.
The company has designed the new clinical trial to establish a treatment method that prevents the disease from becoming severe, based on a Phase 3 trial conducted last year.
The new Phase 3 study in Japan targets patients with early-onset Covid-19, who present risk factors for progression to severe symptoms.
Covid-19 patients aged 50 years and older, at risk of developing serious conditions including underlying diseases and obesity will be enrolled within 72 hours of onset.
The ratio of patients whose condition has become severe compared to the placebo group is the primary endpoint of the study.
Furthermore, Fujifilm Group said that it is planning to make the drug available to Covid-19 patients as early as possible.