TOKYO: Japan’s health ministry has approved an oral Covid-19 drug developed by the American pharmaceutical firm Merck & Co, making it the first such pill to be used in the country.
Molnupiravir, which prevents the novel coronavirus from multiplying in the body, was given the green light under a fast-track process after MSD KK, 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. Patients 18 or older with mild symptoms will be able to take the pill twice a day for five days.
Prime Minister Fumio Kishida said that 200,000 doses of the pill would be delivered nationwide from this weekend if approved. The government has already agreed with Merck on the procurement of 1.6 million doses.
Health minister Shigeyuki Goto said the drug was expected to be available at medical institutions as early as Monday. The ministry will work with drugstores to enable the treatment to be taken at home to reduce contact between patients and others
Molnupiravir, also approved in Britain in November, has drawn attention as the world’s first approved Covid-19 treatment that can be taken orally. But British 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 granted emergency use authorisation for the pill on Thursday but emphasised that it should only be used when other authorised treatments for Covid are inaccessible or clinically inappropriate.
Clinical trial data have shown that patients given the drug within five days of developing coronavirus symptoms were 30% less likely to be hospitalised or die than 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 the oral drug halves the risk of hospitalisation and death. But the percentage was revised downward after the company increased the number of trial participants.
The US FDA on Wednesday also issued an emergency use authorisation for Paxlovid, a pill against Covid 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 officially approved in Japan.
Earlier this month, Pfizer said the pill had shown nearly 90% efficacy in preventing hospitalisation or death in high-risk patients, citing final study results.
