TOKYO -- The Japanese health ministry's expert board on Monday postponed a decision on whether to approve Fujifilm Holdings' Avigan for coronavirus treatment, opting to examine more evidence to determine its efficacy.
"This is not a rejection of Avigan's effectiveness," a ministry representative said. The board will continue with its deliberations once additional clinical trial results come out, with a decision now expected no earlier than January.
Fujifilm called the ministry's decision extremely regrettable.
The company has sought approval for Avigan, originally developed for the flu by unit Fujifilm Toyama Chemical, as a coronavirus treatment since October. The drug led to faster recovery times among patients with "non-severe" pneumonia as a complication of COVID-19, according to clinical trial results from the company.
But the ministry's board is believed to have taken issue with the fact that Fujifilm ran a single-blind trial, in which doctors knew which patients received the drug as opposed to a placebo. Single-blind trials are considered less reliable than double-blind trials, where neither patients nor doctors know who receives the drug.
Japan has approved two other drugs, remdesivir and dexamethasone, as coronavirus treatments. But both are intended for patients with severe pneumonia, and Avigan was seen as the first alternative for those with milder symptoms.
The government of then-Prime Minister Shinzo Abe had originally hoped to approve Avigan as a COVID-19 treatment by the end of May. But Fujifilm ran into trouble recruiting clinical trial participants as the country's cases dwindled, leading to a significant delay.
The pandemic has since regained momentum in Japan, with a cumulative 200,000-plus confirmed cases nationwide as of Monday night.