Dec 22 (Nikkei) - 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.
Source: ANNnewsCH
