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Drugmaker Merck unit seeks approval of 1st oral COVID drug in Japan

This file photo provided by Merck & Co. shows their new antiviral medication molnupiravir. (Merck & Co. via AP)

TOKYO (Kyodo) -- The Japanese arm of U.S. pharmaceutical giant Merck & Co. said Friday it has applied for state approval for the production and sale of an oral COVID-19 drug, which if granted could be the first such pill to be used in Japan.

    MSD K.K. said in a press release it is seeking the green light from the Ministry of Health, Labor and Welfare under a fast-track process for the Merck-developed molnupiravir, which prevents the virus from entering or multiplying in the body.

    The Japanese government has already agreed with Merck on the procurement of 1.6 million doses and plans to make the orally administered pill available by the end of the year. The drug, which can be taken at home, is regarded by Japan as vital in fighting the pandemic.

    A panel at the health ministry will discuss the application in mid-December, sources familiar with the matter said, with focus on whether the antiviral drug will be marketed toward patients suffering from mild, moderate or severe symptoms.

    Clinical trial data show 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.

    The subsidiary has said that molnupiravir is likely to be effective against the new Omicron coronavirus variant, which has raised concerns due to its large number of mutations and may be highly transmissible or may pose an increased risk of reinfection.

    The United States, where the approval process for molnupiravir is currently under way, is expected to allow emergency use of the oral medicine for COVID-19 adult patients who are at risk of developing severe symptoms.

    The U.S. Food and Drug Administration advisory panel Tuesday narrowly endorsed the pill, despite concerns over its effectiveness and uncertainty over the drug's safety.

    Britain on Nov. 4 became the first country in the world to approve usage of the drug when it gave the green light for prescribing molnupiravir for people with mild or moderate symptoms and at least one risk factor for developing severe illness.

    The British regulator does not recommend use of the drug for pregnant people, and it is not approved for children.

    Japanese pharmaceutical firm Shionogi & Co. and Pfizer Inc., another U.S. pharmaceutical giant, are also among those working to develop an oral antiviral drug for COVID-19.

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