Japanese multinational and legendary camera-maker Fujifilm said on Wednesday that it will ask the Japanese government to approve its anti-influenza drug Avigan as a coronavirus treatment after a monthslong clinical trial showed the drug speeds up recovery for COVID-19 patients.
The study found that patients who received Avigan recovered in 11.9 days, compared to 14.7 days for patients in a placebo group. All the patients had mild cases of the illness.
Fujifilm Toyama Chemical, a subsidiary of Fujifilm and the developer of the drug, said it will file for regulatory approval to market the drug as a COVID-19 treatment in Japan as early as October.
“We have confirmed, in Phase III clinical trial of Avigan in Japan, that the administration of Avigan to COVID-19 patients with non-serious pneumonia demonstrates shorter time resolution,” Fujifilm Toyama Chemical said in a statement.
Since the pandemic started, Japan has donated supplies of Avigan, also known by its active ingredient name, favipiravir, to over 80 countries after the drug showed some success in treating mild COVID-19 cases in Japan in February. Former Prime Minister Shinzo Abe began a government push to triple the stockpile of Avigan in April, allocating almost $130 million to do so, even before clinical studies of the drug’s efficacy had produced results.
Abe was a vocal proponent of Avigan as a COVID-19 treatment, telling hospitals to provide it to anyone who wanted it and encouraging patients to ask doctors to give them the homegrown Japanese drug.
There are currently no COVID-19 treatments with global, unconditional regulatory approval. If Japan approves Fujifilm’s marketing of Avigan as a COVID-19 treatment, the drug would join a small number of treatments with partial or conditional approval around the world.
The U.S. Food and Drug Administration, for instance, has granted emergency use authorization—a temporary form of approval—to some experimental COVID-19 treatments, including Gilead’s antiviral drug remdesivir, which has also been approved by health regulators in Japan, the EU, and Australia.
The EU last week approved the use of dexamethasone, a steroid, to treat COVID-19 patients who require oxygen therapy or mechanical ventilation. Japan has approved the use of both dexamethasone and remdesivir as COVID-19 treatments.
Fujifilm hasn’t publicly said how much Avigan will cost per patient in Japan. A generic version of the drug that’s approved for use in India costs around $113 per patient, Reuters reported in July.
Toyama Chemical, which became a Fujifilm subsidiary in 2018, secured government approval for Avigan as an influenza treatment in 2014. Before the pandemic, the Japanese government maintained a stockpile of Avigan in case of an influenza outbreak, but the drug was never available on the market, in part due to animal studies conducted prior to its 2014 regulatory approval that found evidence of birth defects.
The drug has a mechanism that prevents the virus from replicating its genetic material, RNA, inside the host cell, and therefore keeps the virus from propagating. The coronavirus, influenza virus, and Ebola virus are all single-stranded RNA viruses.
During the Ebola outbreak in West Africa that began in 2014, the government of Guinea selected Avigan as part of its treatment for Ebola patients.
In February, Japan’s health minister at the time, Katsunobu Kato, said the health ministry would recommend the use of Avigan to treat COVID-19 patients after early test dosages appeared effective for some patients. At the time, there wasn’t conclusive evidence from clinical studies of Avigan’s effectiveness in treating COVID-19.
The Phase III clinical trial of Avigan that ended on Wednesday began in March, Fujifilm said, and included patients with non-severe cases of COVID-19. Other studies of the drug’s effect on COVID-19 in Japan were impeded by a lack of patients, which prevented researchers from gaining statistically significant results.
Fujifilm said in a Wednesday statement that the results from the Phase III trial—which included 156 patients—were statistically significant, and said the trial found no new safety concerns.
Clinical studies in China, completed in mid-March, also pointed to Avigan’s promise as a COVID-19 treatment. Chinese researchers found that patients treated with Avigan had faster recoveries and better improvement in their lung conditions compared to a control group who didn’t receive the treatment.