Fujifilm Holdings Corp will continue research on Avigan into June, Japan’s government said on Tuesday, effectively dashing hopes by Prime Minister Shinzo Abe that the drug would be approved as a COVID-19 treatment this month.Abe had said he hoped the drug would be approved in May if its efficacy and safety could be confirmed.
“The company will continue research into next month or so, and if an application for approval is received from the company, it will be promptly reviewed,” Chief Cabinet Secretary Yoshihide Suga said at a regular briefing when asked about Avigan.
Suga said trials of a coronavirus vaccine could begin as early as July, raising expectations about a candidate developed by Osaka University and biopharmaceutical firm AnGes Inc.
Kyodo News reported late on Monday the government had given up on Avigan’s May timeline. Last week, the news agency said an interim study showed no clear evidence of the drug’s efficacy in COVID-19 cases.
“While we continue with the ongoing clinical trials, Fujifilm will remain in close contact with the regulatory authority and work toward the application for approval at the earliest possible timing,” Fujifilm spokeswoman Kana Matsumoto said on Tuesday.
During an earnings briefing on May 22, Fujifilm Senior Vice President Junji Okada declined to comment on when Avigan might be approved.
Avigan is the subject of at least 16 trials worldwide, though there is concern the drug has been shown to cause birth defects in animal studies.
Japan’s government has called on Fujifilm to triple national stockpiles of Avigan, approved in 2014 as an emergency flu treatment, and pledged to donate it to countries upon request.
Dozens of clinical trials for COVID-19 treatments and vaccines are ongoing globally. The Nikkei newspaper said on Monday AnGes is set to begin a trial of its DNA vaccine in July, rather than September as initially scheduled.