A health ministry panel approved an oral COVID-19 drug on Friday. The pill, developed by U.S. pharmaceutical firm Merck & Co., will be the first of its kind to be used in Japan.
Molnupiravir, which prevents the novel coronavirus from multiplying in the body, was given the green light under a fast-track process after MSD K.K., the Japanese arm of Merck, applied in early December to produce and sell the drug in Japan.
The Japanese subsidiary has said that molnupiravir is also likely effective against the omicron variant of the virus.
Prime Minister Fumio Kishida indicated earlier in the week that 200,000 doses of the pill would be delivered nationwide starting this weekend and made available from next week if approved. The Japanese government has already agreed with Merck on the procurement of 1.6 million doses.
Molnupiravir, also greenlighted in Britain in November, has drawn attention as the world’s first approved COVID-19 treatment which can be taken orally. But British regulators have not recommended its use for pregnant women, and it is not approved for children.
In the U.S., the Food and Drug Administration (FDA) granted emergency use authorization for the pill on Thursday.
Clinical trial data has shown that patients given the drug within five days of developing coronavirus symptoms were 30 percent less likely to be hospitalized or die compared with those given a placebo, according to the Japanese subsidiary.
In an interim report on clinical trials across areas including Japan, Europe and the United States, Merck initially reported that use of the oral drug halves the risk of hospitalization and death. But the percentage was revised downward after the company increased the number of trial participants.
On Wednesday, meanwhile, the U.S. FDA issued an emergency use authorization for Paxlovid, a pill against COVID-19 developed by Pfizer Inc.
The Japanese government has agreed with the American pharmaceutical company on the procurement of 2 million doses, although the pill has not yet been approved in Japan.
Earlier this month, Pfizer said the pill had shown nearly 90 percent efficacy in preventing hospitalization or death in high-risk patients, citing final study results.
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