Fujifilm Begins US Phase II Clinical Trial of Avigan for COVID-19 Patients and Increases Production

FUJIFILM Corporation (Tokyo, Japan) has initiated a US phase II clinical trial to evaluate the safety and efficacy of its influenza antiviral drug Avigan® Tablet (generic name favipiravir) for patients with COVID-19, a respiratory infection caused by the novel SARS-CoV-2 coronavirus. Avigan was the first-ever antiviral medicine to be approved for use as a treatment for COVID-19 in China.

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. Avigan is not approved for distribution in the US or any overseas countries.

Avigan selectively inhibits RNA polymerase necessary for influenza virus replication. Due to its action mechanism, Avigan is expected to potentially have an antiviral effect on the new coronavirus, because similar to influenza viruses, coronaviruses are single-stranded RNA viruses that also depend on viral RNA polymerase. In March, Fujifilm commenced a phase III clinical trial of Avigan for COVID-19 patients in Japan.

The clinical trial of Avigan Tablet in the US will enroll approximately 50 patients with COVID-19, in collaboration with Brigham and Women’s Hospital, Massachusetts General Hospital, and the University of Massachusetts Medical School. FUJIFILM has reaffirmed that it will continue to work to establish a treatment method for COVID-19 patients by conducting clinical trials, and to contribute towards ending the spread of the global pandemic by increasing the production of Avigan in collaboration with its strategic partners. In early March, FUJIFILM had already began increasing its production of Avigan and now plan to accelerate the production of its influenza antiviral drug through cooperation with domestic and overseas partners for responding to the needs of the Japanese government and other countries.