• Kyodo, Jiji

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The Japanese arm of U.S. pharmaceutical giant Merck & Co. 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 news release Friday 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 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.

The drug, which would be available on a prescription basis, is expected to reduce the risk of developing serious symptoms, hopefully easing the burden on the country's medical care system.

In clinical trials conducted in Japan, the United States and elsewhere, molnupiravir reduced the risk of hospitalization and death by about 30% for mildly and moderately ill COVID-19 patients.

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 underway, is expected to allow emergency use of the 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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