Japanese Prime Minister Shinzo Abe is set to grant Gilead Sciences' experimental COVID-19 drug remdesivir a special, speedy approval, despite it failing to show any definitive clinical signs that it works.
The report, from Japanese news site Kyodo, could make Japan the first country in the world to approve the med, which was once being tested for Ebola. A green light for the med could come as early as May, Kyodo reports.
“The pharmaceutical approval (of remdesivir) will be possible shortly,” Abe told a parliamentary session, as quoted by the news agency. Gilead will have to make an application for an approval, at which time the Japanese government is set to fast-track its way to market.
The streamlining of the normal process involves postponing reports on domestic clinical tests to a later date.
It’s the most keenly watched investigational asset for COVID-19 (and possibly for any disease) in the world right now, but it's yet to provide any real clarity on whether it can help patients with the virus.
It’s currently undergoing trials in Europe and the U.S. and had been under investigation in China, although enrollment issues have scuppered several tests there.
Some data have been made public, both officially and unofficially, but these have mainly led to arguments over whether the drug can show a benefit. There are a host of other treatments being tested against the disease, but most are at a much earlier stage or have been red-flagged due to safety issues.
A safe, efficacious vaccine remains the holy grail of COVID-19 research, but any vaccination program is unlikely to be ready until at least next year.
This also comes as Reuters reports data from a key U.S. test of the drug could be available in weeks, according to the study’s lead investigator, which would be way ahead of schedule.
Preliminary findings from the randomized trial of remdesivir, which was started back in February by the National Institute of Allergy and Infectious Diseases, “could come even sooner,” lead researcher Andre Kalil, M.D., told Reuters in an interview.
Japan currently has about 13,000 cases of the disease and less than 400 deaths, although in recent weeks the country has issued tougher lockdown measures to combat the spread. It was set to host the Olympic and Paralympic Games this summer, but those have now been postponed until 2021.