Japan to grant approval to Gilead’s remdesivir potentially in May

Japan is on the verge of approving Gilead Sciences’ experimental COVID-19 drug remdesivir on a special basis outside of the normal process that will grant a quicker approval that postpones reports on domestic clinical tests until later. Gilead still need to submit their application but once it is in, the Japanese government is set to fast-track its way to market. The prime minister told a parliamentary session “the pharmaceutical approval (of remdesivir) will be possible shortly”.

Remdesivir was at one point being tested for Ebola and is currently in trials in the USA and Europe. The US study’s lead investigator, Andre Kalil , said data from preliminary findings from the randomized trial of remdesivir, which the National Institute of Allergy and Infectious Diseases commenced in February, could be available in a matter of weeks, or in his words “could come even sooner” which if accurate would be ahead of schedule by some margin.