TOKYO -- Fujifilm Holdings will soon apply to produce and sell its Avigan antiviral drug as a treatment for the new coronavirus in Japan, Nikkei learned Sunday.
The health ministry could give the go-ahead this year, making Avigan the third drug overall and the first domestically developed drug to receive such approval. Japan previously approved dexamethasone and remdesivir as coronavirus treatments.
Avigan, whose generic name is favipiravir, was originally developed as a flu treatment by what is now Fujifilm Toyama Chemical. Clinical trials for COVID-19 began in March and concluded in September. While the results are still under review, the drug apparently showed some effectiveness against the coronavirus.
Avigan is already administered to coronavirus patients at certain medical institutions as part of observational studies. Approval as an official treatment will allow wider use.
Avigan cannot be used on pregnant women, since it has been found to possibly cause birth defects.
The health ministry has said it plans to fast-track approval for the drug. "If the data from the clinical trials looks good, we could approve it in a month from when Fujifilm submits an application," a ministry source said.
Then-Prime Minister Shinzo Abe had said back in May that he aimed to have Avigan approved as a coronavirus treatment by the end of that month. The plan ultimately fell through over difficulties securing enough subjects for trials.