TOKYO — Japan on Saturday began fast-track approval of remdesivir, Gilead Sciences’ antiviral drug intended to treat coronavirus patients, Nikkei has learned. It has also asked the U.S. to ensure Japan receives adequate supplies of the drug.
The move follows emergency approval of remdesivir by the U.S. on Friday. Moves are underway to do the same in Japan, and to secure supplies from the U.S.
Remdesivir, originally developed as a treatment for Ebola by U.S. drugmaker Gilead, has gained global attention as a candidate treatment for people with severe COVID-19 symptoms.
Japan will launch expedited authorization procedures for the antiviral drug. This will allow reporting of domestic clinical trials to be postponed to a later date. The streamlined process is allowed in cases where a drug has been approved for use overseas.
The cabinet will hold a meeting later on Saturday to work out an amendment to the relevant ordinance. The health ministry will then work toward a quick approval to allow the antiviral to be used in Japan.
Tokyo has asked Washington for a steady supply of remdesivir. There are concerns in the government over supplies, and that U.S. may lack sufficient capacity to ensure that Japan gets the medicine it needs. The government hopes to work with its counterparts in Washington to smooth procurement.
According to Japanese officials, the two countries have discussed ways to secure the drug ahead of the drug’s approval in Japan. So far, there has been no clear response from the U.S. Some officials have expressed concern that even if remdesivir is approved, most of the drug will go to the U.S., slowing delivery of the antiviral to Japan.