Japanese government panel approves first COVID-19 oral pill
A Department of Health panel on Friday approved a COVID-19 oral drug. The pill, developed by the American pharmaceutical company Merck & Co., will be the first of its kind to be used in Japan.
Molnupiravir, which prevents the new coronavirus from multiplying in the body, received the green light in an accelerated process after MSD KK, the Japanese arm of Merck, asked in early December to produce and sell the drug in Japan.
The Japanese subsidiary said molnupiravir is also likely effective against the omicron variant of the virus.
Prime Minister Fumio Kishida said earlier in the week that 200,000 doses of the pill would be delivered nationwide from this weekend and made available from next week if approved. The Japanese government has already agreed with Merck to purchase 1.6 million doses.
Molnupiravir, also approved in Britain in November, gained attention as the world’s first approved COVID-19 treatment that can be taken orally. But UK regulators have not recommended its use for pregnant women, and it is not approved for children.
In the United States, the Food and Drug Administration (FDA) granted emergency use authorization for the pill on Thursday.
Data from clinical trials showed that patients who received the drug within five days of developing symptoms of the coronavirus were 30% less likely to be hospitalized or die than those who received a placebo, according to the Japanese subsidiary.
In an interim report on clinical trials in regions such as Japan, Europe and the United States, Merck initially reported that oral use of the drug halved the risk of hospitalization and death. But the percentage was revised downwards after the company increased the number of trial participants.
Meanwhile, the US FDA on Wednesday issued an emergency use authorization for Paxlovid, a COVID-19 pill developed by Pfizer Inc.
The Japanese government has agreed with the US pharmaceutical company to purchase 2 million doses, although the pill has yet to be approved in Japan.
Earlier this month, Pfizer said the pill had shown nearly 90% effectiveness in preventing hospitalization or death in high-risk patients, citing the study’s final results.
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